Bone fusion surgical system and method

ABSTRACT

A bone fusion method, system and device for insertion between bones that are to be fused together and/or in place of one or more of the bones, such as, for example, the vertebrae of a spinal column. The bone fusion device comprises one or more extendable tabs having a central rib. The bone fusion device includes one or more support channels configured to receive an insertion instrument that is then secured to the bone fusion device via a coupling mechanism. As a result, the coupled device is able to be securely positioned between vertebrae using the insertion instrument with minimal risk of slippage.

FIELD OF THE INVENTION

This invention relates generally to bone fusion systems. Morespecifically, the present invention relates to systems for fusingvertebrae of the spine or other bones.

BACKGROUND OF THE INVENTION

The spinal column is made up of vertebrae stacked on top of one another.Between the vertebrae are discs which are gel-like cushions that act asshock-absorbers and keep the spine flexible. Injury, disease, orexcessive pressure on the discs can cause degenerative disc disease orother disorders where the disc becomes thinner and allows the vertebraeto move closer together or become misaligned. Similarly, vertebrae areable to weaken due to impact or disease reducing their ability toproperly distribute forces on the spine. As a result, nerves may becomepinched, causing pain that radiates into other parts of the body, orinstability of the vertebrae may ensue.

One method for correcting disc and/or vertebrae-related disorders is toinsert a fusion cage as a replacement for and/or in between thevertebrae to act as a structural replacement for the deteriorated discand/or vertebrae. The fusion cage is typically a hollow metal deviceusually made of titanium. Once inserted, the fusion cage maintains theproper separation between the vertebrae to prevent nerves from beingpinched and provides structural stability to the spine. Also, the insideof the cage is filled with bone graft material which eventually fusespermanently with the adjacent vertebrae into a single unit. However, itis difficult to retain this bone graft material in the cage and in theproper positions to stimulate bone growth.

The use of fusion cages for fusion and stabilization of vertebrae in thespine is known in the prior art. U.S. Pat. No. 4,961,740 to Ray, et al.entitled, “V-Thread Fusion Cage and Method of Fusing a Bone Joint,”discloses a fusion cage with a threaded outer surface, where the crownof the thread is sharp and cuts into the bone. Perforations are providedin valleys between adjacent turns of the thread. The cage can be screwedinto a threaded bore provided in the bone structure at the surgical siteand then packed with bone chips which promote fusion.

U.S. Pat. No. 5,015,247 to Michelson entitled, “Threaded SpinalImplant,” discloses a fusion implant comprising a cylindrical memberhaving a series of threads on the exterior of the cylindrical member forengaging the vertebrae to maintain the implant in place and a pluralityof openings in the cylindrical surface.

U.S. Pat. No. 6,342,074 to Simpson entitled, “Anterior Lumbar UnderbodyFusion Implant and Method For Fusing Adjacent Vertebrae,” discloses aone-piece spinal fusion implant comprising a hollow body having anaccess passage for insertion of bone graft material into theintervertebral space after the implant has been affixed to adjacentvertebrae. The implant provides a pair of screw-receiving passages thatare oppositely inclined relative to a central plane. In one embodiment,the screw-receiving passages enable the head of an orthopaedic screw tobe retained entirely within the access passage.

U.S. Pat. No. 5,885,287 to Bagby entitled, “Self-tapping Interbody BoneImplant,” discloses a bone joining implant with a rigid, implantablebase body having an outer surface with at least one bone bed engagingportion configured for engaging between a pair of bone bodies to bejoined, wherein at least one spline is provided by the bone bed engagingportion, the spline being constructed and arranged to extend outwardlyof the body and having an undercut portion.

U.S. Pat. No. 6,582,467 to Teitelbaum et al. entitled,“Expandable FusionCage,” discloses an expandable fusion cage where the surfaces of thecage have multiple portions cut out of the metal to form sharp barbs. Asthe cage is expanded, the sharp barbs protrude into the subcortical boneof the vertebrae to secure the cage in place. The cage is filled withbone or bone matrix material.

U.S. Pat. No. 5,800,550 to Sertich entitled, “Interbody Fusion Cage,”discloses a prosthetic device which includes an inert generallyrectangularly shaped support body adapted to be seated on hard endplates of vertebrae. The support body has top and bottom faces. A firstpeg is movably mounted in a first aperture located in the support body,and the first aperture terminates at one of the top and bottom faces ofthe support body. Further, the first peg projects away from the one ofthe top and bottom faces and into an adjacent vertebra to secure thesupport body in place relative to the vertebra.

U.S. Pat. No. 6,436,140 to Liu et al. entitled, “Expandable InterbodyFusion Cage and Method for Insertion,” discloses an expandable hollowinterbody fusion device, wherein the body is divided into a number ofbranches connected to one another at a fixed end and separated at anexpandable end. The expandable cage may be inserted in its substantiallycylindrical form and may be expanded by movement of an expansion memberto establish lordosis of the spine. An expansion member interacts withthe interior surfaces of the device to maintain the cage in the expandedcondition and provide a large internal chamber for receiving bonein-growth material.

These patents all disclose fusion cage devices that can be insertedbetween vertebrae of the spine in an invasive surgical procedure. Suchan invasive surgical procedure requires a long recovery period.

SUMMARY OF THE INVENTION

The present application is directed to a bone fusion system, method anddevice for insertion of a bone fusion device between bones that are tobe fused together and/or in place of one or more of the bones, such as,for example, the vertebrae of a spinal column. The bone fusion devicecomprises one or more extendable plates having a central rib. The bonefusion device is able to be inserted between or replace the vertebrae byusing an minimally invasive procedure. The bone fusion device comprisesone or more support channels configured to receive an insertioninstrument that is then secured to the bone fusion device via a couplingmechanism. As a result, the coupled device is able to be securelypositioned between vertebrae using the insertion instrument with minimalrisk of slippage. After the device has been positioned between thevertebrae, and the screw is rotated by the control mechanism to deliverthe bone graft material and extend the plates. Two tabs or plates areextended upon rotating a rotating means wherein extending blocks travelup the screw pushing out the angled plates as the extending blocksapproach the ends of the bone fusion device. The central rib of the tabsprovides increased support against torsional forces creating more stablecontact with the bones. In some embodiments, a single tab is extended.Thus, the tabs are able to be advantageously positioned in the confinedspace between the vertebrae to help brace the device until the bone hasfused.

One aspect of the present application is directed to a bone fusionsurgical system for manipulating a bone fusion device in a desiredlocation. The system comprises a bone fusion device having a body withone or more device channels, a positioning element having a positioningaperture and one or more extendable tabs, wherein manipulation of thepositioning element enables the tabs to be extended away from the bodyand a rescue hook rod having an elongated arm with a base handle at afirst end and a hook at a second end opposite the first end, wherein asurface of the base handle includes a first visual indicator thatindicates an orientation of the hook with respect to the base handle. Insome embodiments, at least one of the device channels has a channelheight and is positioned along a side of the bone fusion device suchthat a perimeter of the one of the device channels is defined by a sidewall of the body, wherein the side wall has a side wall width. In someembodiments, the hook forms a U-shape and the width of the U-shape isslightly greater than the side wall width such that the side wall isable to slide into the hook within the U-shape. In some embodiments, theU-shape formed by the hook parallel to a plane, and perpendicular to theplane, the hook has a hook width that is less than the channel heightsuch that the hook is able to slide into the channel. In someembodiments, the first visual indicator is positioned on a first side ofthe base handle and a second visual indicator is positioned on a secondside of the base handle, wherein the second visual indicator indicatesthe orientation of the hook with respect to the base handle. In someembodiments, the system further comprises an insertion instrument havinga coupling mechanism having a control rod and a plurality of fingersconfigured to move between a closed position wherein the fingers areclose together to a spread position wherein the fingers are fartherapart based on manipulation of the control rod. In some embodiments, thecontrol rod has a hollow axial cavity that extends from a bottom of theplurality of fingers to an opposite end of the instrument. In someembodiments, the system further comprises a measuring tool comprising ahousing including a gear chamber and a screw chamber, a screw thatextends through the screw chamber and is rotatably coupled within thehousing such that the screw is able to rotate about a screw axis withinthe screw chamber, an indicator ring threaded onto the screw within thescrew chamber such that rotation of the screw causes the ring to move upor down the screw a distance along the screw axis, a screw gearpositioned within the gear chamber and coupled to a first screw end endof the screw and centered around the screw axis such that rotation ofthe screw gear causes rotation of the screw and an offset gearpositioned within the gear chamber offset from the screw axis andoperably coupled with the screw gear such that rotation of the gearwheel causes the screw gear to correspondingly rotate, wherein a numberof rotations of the screw gear in a direction is proportional to thedistance moved by the ring caused by the rotation of the screw gear. Insome embodiments, the method further comprises an engaging toolcomprising a engaging handle having a bottom, an elongated member havinga tip end including a contoured tip and a coupling end opposite the tipend and coupled to the bottom of the engaging handle and an interfacegear having a set of teeth and coupled to the bottom of the engaginghandle such that the set of teeth are centered around the elongatedmember. In some embodiments, the system further comprises a deliveryapparatus including a docking rod and a delivery member having anelongated hollow shaft that leads to an exit aperture, wherein a tip ofthe docking rod detachably couples to the bone fusion device within thepositioning aperture and the delivery member detachably couples with thedocking rod such that the exit aperture aligns with the one of thedevice channels when the docking rod is coupled to the bone fusiondevice. In some embodiments, the delivery apparatus includes a rigidplunger comprising a rigid plunger handle, a plunger head, a plunger rodhaving a first rod end coupled to the rigid plunger handle and a secondrod end coupled to the plunger head, wherein the plunger rod has athreaded portion between the rigid plunger handle and the plunger headand a plunger hollow tubular cap having an opening at a first cap end, awall including a screw aperture at a second cap end and a threaded innertubular wall between the first cap end and the second cap end, whereinan inner surface of the screw aperture is threaded and the plungerhollow tubular cap is threaded onto threaded portion of the plunger rodin between the rigid plunger handle and the plunger head. In someembodiments, the delivery apparatus includes a flexible plungercomprising a gripping handle, a first flexible rod, a second flexiblerod and a sleeve coupled with the gripping handle, wherein the sleeveholds the first flexible rod adjacent to the second flexible rod in anarea such that the first and second flexible rods are held next to eachother within the area, but able to flex away from each other outside ofthe area. In some embodiments, the system further comprises anadditional rescue hook rod that matches the rescue hook rod

A second aspect is directed to a bone fusion surgical system formanipulating a bone fusion device in a desired location. The systemcomprises a bone fusion device having a body with one or more devicechannels, a positioning element having a positioning aperture and one ormore extendable tabs, wherein manipulation of the positioning elementenables the tabs to be extended away from the body, an insertioninstrument having a coupling mechanism having a control rod and aplurality of fingers configured to move between a closed positionwherein the fingers are close together to a spread position wherein thefingers are farther apart based on manipulation of the control rod and aredocking rod having a central axis, a redocking tip and a redockinghandle opposite the redocking tip, wherein the redocking tip isconfigured to detachably couple to the bone fusion device by slidinginto the positioning aperture forming a friction coupling between theredocking tip and the positioning aperture. In some embodiments, thecontrol rod has a hollow axial cavity that extends from a bottom of theplurality of fingers to an opposite end of the instrument. In someembodiments, the redocking rod is sized such that the redocking rod isable to slide through the hollow axial cavity of the insertioninstrument when the central axis of the redocking rod is aligned withthe hollow axial cavity. In some embodiments, a length of the redockingrod along the central axis is greater than a length of the insertioninstrument along the hollow axial cavity such that when inserted intothe hollow axial cavity the redocking rod protrudes from one or bothsides of the hollow axial cavity. In some embodiments, the systemfurther comprises a measuring tool comprising a housing including a gearchamber and a screw chamber, a screw that extends through the screwchamber and is rotatably coupled within the housing such that the screwis able to rotate about a screw axis within the screw chamber, anindicator ring threaded onto the screw within the screw chamber suchthat rotation of the screw causes the ring to move up or down the screwa distance along the screw axis, a screw gear positioned within the gearchamber and coupled to a first screw end end of the screw and centeredaround the screw axis such that rotation of the screw gear causesrotation of the screw and an offset gear positioned within the gearchamber offset from the screw axis and operably coupled with the screwgear such that rotation of the gear wheel causes the screw gear tocorrespondingly rotate, wherein a number of rotations of the screw gearin a direction is proportional to the distance moved by the ring causedby the rotation of the screw gear. In some embodiments, the systemfurther comprises an engaging tool comprising a engaging handle having abottom, an elongated member having an engaging tip end including acontoured tip and a coupling end opposite the tip end and coupled to thebottom of the engaging handle and an interface gear having a set ofteeth and coupled to the bottom of the engaging handle such that the setof teeth are centered around the elongated member. In some embodiments,the system further comprises a delivery apparatus including a dockingrod and a delivery member having an elongated hollow shaft that leads toan exit aperture, wherein a tip of the docking rod detachably couples tothe bone fusion device within the positioning aperture and the deliverymember detachably couples with the docking rod such that the exitaperture aligns with the one of the device channels when the docking rodis coupled to the bone fusion device. In some embodiments, the deliveryapparatus includes a rigid plunger comprising a rigid plunger handle, aplunger head, a plunger rod having a first rod end coupled to the rigidplunger handle and a second rod end coupled to the plunger head, whereinthe plunger rod has a threaded portion between the rigid plunger handleand the plunger head and a plunger hollow tubular cap having an openingat a first cap end, a wall including a screw aperture at a second capend and a threaded inner tubular wall between the first cap end and thesecond cap end, wherein an inner surface of the screw aperture isthreaded and the plunger hollow tubular cap is threaded onto threadedportion of the plunger rod in between the rigid plunger handle and theplunger head. In some embodiments, the delivery apparatus includes aflexible plunger comprising a gripping handle, a first flexible rod, asecond flexible rod and a sleeve coupled with the gripping handle,wherein the sleeve holds the first flexible rod adjacent to the secondflexible rod in an area such that the first and second flexible rods areheld next to each other within the area, but able to flex away from eachother outside of the area.

A third aspect is directed to a method of operation of a bone fusionsystem. The method comprises providing a bone fusion device in a desiredlocation, the bone fusion device having a body with one or more devicechannels, a positioning element having a positioning aperture and one ormore extendable tabs, wherein manipulation of the positioning elementenables the tabs to be extended away from the body, providing a rescuehook rod having an elongated arm with a base handle at a first end and ahook at a second end opposite the first end, wherein a surface of thebase handle includes a first visual indicator that indicates anorientation of the hook with respect to the base handle, coupling therescue hook rod with the bone fusion device by inserting the hook intoone of the device channels and repositioning the bone fusion device bymanipulating the rescue hook rod. In some embodiments, at least one ofthe device channels has a channel height and is positioned along a sideof the bone fusion device such that a perimeter of the one of the devicechannels is defined by a side wall of the body, wherein the side wallhas a side wall width. In some embodiments, the hook forms a U-shape andthe width of the U-shape is slightly greater than the side wall widthsuch that the side wall is able to slide into the hook within theU-shape. In some embodiments, the U-shape formed by the hook parallel toa plane, and perpendicular to the plane, the hook has a hook width thatis less than the channel height such that the hook is able to slide intothe channel. In some embodiments, the first visual indicator ispositioned on a first side of the base handle and a second visualindicator is positioned on a second side of the base handle, wherein thesecond visual indicator indicates the orientation of the hook withrespect to the base handle. In some embodiments, the method furthercomprises providing an insertion instrument having a coupling mechanismhaving a control rod and a plurality of fingers configured to movebetween a closed position wherein the fingers are close together to aspread position wherein the fingers are farther apart based onmanipulation of the control rod. In some embodiments, providing the bonefusion device in the desired location comprises spreading the pluralityof fingers with the control rod, sliding the fingers into one or more ofthe channels of the bone fusion device, contracting the fingers with thecontrol rod such that the fingers move into the one or more of thechannels and the insertion instrument is detachably coupled with thebone fusion device and positioning the bone fusion device into thedesired position by manipulating the insertion instrument. In someembodiments, the method further comprises providing an additional rescuehook rod that matches the rescue hook rod, coupling the additionalrescue hook rod with the bone fusion device by inserting an additionalhook of the additional rescue hook rod into a different one of thedevice channels, wherein repositioning the bone fusion device includesmanipulating both the rescue hook rod and the additional rescue hookrod.

A fourth aspect is directed to a method of operation of a bone fusionsystem. The method comprises providing a bone fusion device in a desiredlocation, the bone fusion device having a body with one or more devicechannels, a positioning element having a positioning aperture and one ormore extendable tabs, wherein manipulation of the positioning elementenables the tabs to be extended away from the body, providing aredocking rod having a central axis, a redocking tip and a redockinghandle opposite the redocking tip and detachably coupling the redockingrod to the bone fusion device by sliding the redocking tip into thepositioning aperture forming a friction coupling between the redockingtip and the positioning aperture. In some embodiments, the methodfurther comprises providing an insertion instrument having a couplingmechanism having a control rod and a plurality of fingers configured tomove between a closed position wherein the fingers are close together toa spread position wherein the fingers are farther apart based onmanipulation of the control rod, and further wherein the control rod hasa hollow axial cavity that extends from a bottom of the plurality offingers to an opposite end of the instrument. In some embodiments, themethod further comprises sliding the insertion instrument onto theredocking rod such that the redocking rod moves through the hollow axialcavity until the coupling mechanism meets the bone fusion device coupledto the redocking tip of the redocking rod and detachably coupling theinsertion instrument to the bone fusion device. In some embodiments, alength of the redocking rod along the central axis is greater than alength of the insertion instrument along the hollow axial cavity suchthat when inserted into the hollow axial cavity the redocking rodprotrudes from one or both sides of the hollow axial cavity. In someembodiments, detachably coupling the insertion instrument to the bonefusion device comprises spreading the plurality of fingers with thecontrol rod, sliding the fingers into one or more of the channels of thebone fusion device and contracting the fingers with the control rod suchthat the fingers move into the one or more of the channels and theinsertion instrument is detachably coupled with the bone fusion device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a top perspective view of the bone fusion deviceaccording to some embodiments.

FIG. 1B illustrates a top cutout view of the bone fusion deviceaccording to some embodiments.

FIG. 2 illustrates a side perspective view of the bone fusion deviceaccording to some embodiments.

FIG. 3 illustrates a cross-sectional view of components of the bonefusion device according to some embodiments.

FIG. 4A illustrates a cross sectional view of the bone fusion devicewith the tabs compacted according to some embodiments.

FIG. 4B illustrates a cross sectional view of the bone fusion devicewith the tabs extended according to some embodiments.

FIG. 5 illustrates a profile view of a bone fusion device having asingle tab extension/retraction mechanism according to some embodiments.

FIGS. 6A and 6B illustrate a front and a side view of a bone fusiondevice having one or more protruding tabs according to some embodiments.

FIGS. 7A-7C illustrate a front, side and top view of a bone fusiondevice having one or more protruding rails according to someembodiments.

FIG. 8 illustrates a bone fusion apparatus according to someembodiments.

FIG. 9A illustrates a side view of the insertion instrument according tosome embodiments.

FIG. 9B illustrates a side cross-sectional view of the insertioninstrument according to some embodiments.

FIG. 9C illustrates a perspective exploded view of the insertioninstrument according to some embodiments.

FIG. 10A illustrates an insertion instrument having fingers in a spreadposition according to some embodiments.

FIG. 10B illustrates an insertion instrument having fingers in a closedposition according to some embodiments.

FIG. 10C illustrates an insertion instrument having fingers in a spreadposition according to some embodiments.

FIG. 10D illustrates an insertion instrument having fingers in a closedposition according to some embodiments.

FIGS. 11A-11D illustrate perspective, top, front and back views,respectively, of a measuring tool according to some embodiments.

FIGS. 11E-11H illustrate perspective, top, front and back views,respectively, of a measuring tool according to some embodiments.

FIG. 12 illustrates a bone fusion device engaging tool according to someembodiments.

FIG. 13 illustrates a bone fusion device insertion and measuring systemaccording to some embodiments.

FIG. 14 illustrates a flow chart of a method of operation of the bonefusion system according to some embodiments.

FIG. 15 illustrates a bone fusion device system according to someembodiments.

FIGS. 16A-D illustrate a top, side cross-sectional, perspective andfront view, respectively, of the delivery member according to someembodiments.

FIG. 17 illustrates the docking rod according to some embodiments.

FIGS. 18A-D illustrate an exploded perspective view, a side view, a sidecross-sectional view and a frontal view, respectively, of a short rigidplunger of the plungers according to some embodiments.

FIGS. 19A and 19B illustrate an exploded perspective view and a frontalview, respectively, of a long rigid plunger of the plungers according tosome embodiments.

FIGS. 20A-C illustrate an exploded perspective view, a side view and afrontal view, respectively, of a flexible plunger of the plungersaccording to some embodiments.

FIG. 21 illustrates a method of operation of the bone fusion systemaccording to some embodiments.

FIG. 22 illustrates a redocking tool according to some embodiments.

FIG. 23 illustrates a method of redocking with a bone fusion deviceaccording to some embodiments.

FIGS. 24A and 24B illustrate a rescue hook according to someembodiments.

FIG. 25 illustrates a method of using a rescue hook according to someembodiments.

DETAILED DESCRIPTION

In the following description, numerous details and alternatives are setforth for purpose of explanation. However, one of ordinary skill in theart will realize that the invention can be practiced without the use ofthese specific details. For instance, the figures and description belowoften refer to the vertebral bones of a spinal column. However, one ofordinary skill in the art will recognize that some embodiments of theinvention are practiced for the fusion of other bones, including brokenbones and/or joints. In other instances, well-known structures anddevices are shown in block diagram form in order not to obscure thedescription of the invention with unnecessary detail.

FIGS. 1A and 1B illustrate a top perspective and cutout view of the bonefusion device 100 according to some embodiments. As shown, the bonefusion device 100 has a substantially rectangular shape and has two endfaces. The bone fusion device 100 is able to be constructed from a highstrength biocompatible material, such as titanium, which has thestrength to withstand forces in the spine that are generated by apatient's body weight and daily movements. Alternatively, part of all ofthe bone fusion device 100 is able to be constructed from one or more ofthe group consisting of high strength biocompatible material or apolymer such as PEEK, PEKK, and other polymeric materials know to bebiocompatible and having sufficient strength. In some embodiments, thematerials used to construct the bone fusion device include usingadditives, such as carbon fibers for better performance of the materialsunder various circumstances. The base biocompatible material is oftentextured or coated with a porous material conducive to the growth of newbone cells on the bone fusion device 100. In some embodiments, theporous material or coating is able to be a three-dimensional open-celledtitanium scaffold for bone and tissue growth (e.g. an OsteoSyncstructure). For example, the coating is able to be a osteosync structurehaving a mean porosity of 50-70%, pore sizes ranging from 400-700 μm,and/or a mean pore interconnectivity of 200-300 μm. Alternatively,instead of a coating on the bone fusion device 100, the porous materialis able to be integrated into the frame and component of the bone fusiondevice 100. The bone fusion device 100 is able to have several conduitsor holes 120 (also see FIG. 2) which permit the bone graft material tobe inserted into the device 100 and to contact the vertebral bone beforeor after the device 100 has been inserted between the vertebrae of thepatient. The bone graft material and the surface texturing (e.g. porousmaterial coating) of the device 100 encourage the growth and fusion ofbone from the neighboring vertebrae. The fusion and healing process willresult in the bone fusion device 100 aiding in the bridging of the bonebetween the two adjacent vertebral bodies of the spine which eventuallyfuse together during the healing period.

As further illustrated in FIGS. 1A and 1B, tabs 130 are located onopposing sides of the bone fusion device 100. The tabs 130 are shaped sothat their outer surface is substantially flush with the frame 114 ofthe bone fusion device 100 in a nonextended position. Internally, thetabs 130 have a full or partial central rib 124 and an angled innersurface. Specifically, the central rib 124 is configured to providefurther outer surface area and structural support to the tabs 130.Further, each tab 130 is shaped such that one or more angled surfaces123 of the tab 130 for extending the tab 130 have end thicknesses thatare larger than their middle thicknesses such that the thickness of theangled surfaces 123 gradually increases while going from the middle tothe ends of the tab 130. A positioning component 108 within the frame114 of the bone fusion device 100 comprises a positioning aperture 134,a first screw 102 and a second screw 104 coupled together (see FIGS. 4Aand 4B). The positioning aperture 134 is configured to receive adrive/engaging mechanism of a tool such that the tool is able to rotateor otherwise manipulate the positioning component 108. The positioningaperture 134 is able to comprise numerous shapes and sizes as are wellknown in the art. The first screw 102 is threaded opposite of the secondscrew 104. For example, if the first screw 102 is left threaded, thesecond screw 104 is right threaded or vice-versa. Furthermore, the firstscrew 102 (see FIG. 2) is of a slightly different size than the secondscrew 104. The positioning component 108 is coupled to a first extendingblock 110 and a second extending block 112, each having a pair of ribslots 126 configured to receive the central ribs 124 of the tabs 130(see FIG. 1B). Specifically, the rib slots 126 are sized such that theypermit the central ribs 124 to slide into and out of the slots 126(depending on the position of the blocks 110, 112) such that whenpositioned within the slots 126, the blocks 110, 112 are able to supportthe tabs 130 against torsional forces by holding and supporting thecentral ribs 124.

Further, the first extending block 110 is coupled to the first screw 102and the second extending block 112 is coupled to the second screw 104,and the first extending block 110 and the second extending block 112 arepositioned in the middle of the bone fusion device 100 in the compactposition. When the positioning component 108 is turned appropriately,the extending blocks 110 and 112 each travel outwardly on theirrespective screws 102 and 104. As the extending blocks 110 and 112travel outwardly, they push the tabs 130 outward and the central ribs124 slide within the rib slots 126. In other words, the inner tabsurface 123 when in contact with the extending blocks 110, 112 act insuch a manner so as to push the respective tabs 130 apart. Specifically,the angled surfaces 111 of each extending block 110, 112 are able to bein contact with the tab surfaces 123 and the center rib surface 121 isin contact with the extending block slot surface 125. Thus, the tabs 130will be fully extended when the extending blocks 110 and 112 reach theopposite ends of the screws 102, 104. To retract the tabs 130, thepositioning device 108 is turned in the opposite direction and theextending blocks 110 and 112 will each travel back to the middle ontheir respective screws 102 and 104 with the central ribs 124 within therib slots 126 enabling the tabs 130 to move into the retracted positiondue to gravity or another downward force. When the extending blocks 110and 112 are positioned in the middle of the bone fusion device 100, thetabs 130 are compact and are within the frame 114 of the bone fusiondevice 100. In some embodiments, the extending blocks 110 and 112 arecoupled to the tabs 130 such that they apply the needed downward forceto retract the tabs. Alternatively, the tabs 130 are able to be biasedwith a biasing mechanism that applies the downward force needed to causethe tabs 130 to retract when enabled by the position of the extendingblocks 110, 112. For example, one or more springs are able to be coupledto the tabs 130, wherein the springs apply a retraction biasing force tothe tabs 130 that causing the tabs to retract when enabled by theextending blocks 110, 112.

It is contemplated that the operation of the device 100 is able to bereversed such that the tabs 130, extending blocks 110, 112, andpositioning components 108 are configured such that the extending blocks110, 112 travel inwardly to extend the tabs 130 into the extendedposition and travel outwardly to retract the tabs 130 into the compactposition. Further, it is contemplated that the positioning component 108is able to be a non-rotational or other type of force generatingmechanism that is able to move the extending blocks 110, 112. Forexample, the positioning component 108 is able to be a mechanism where anon-rotational movement (e.g. in/out of the device 100) causes themovement of the extending blocks 110, 112. In any case, the nonextendedtabs 130 of the bone fusion device 100 provide a compact assembly thatis suitable for insertion into the patient's body through a open, orminimally invasive surgical procedure. As used herein, an open or aminimally invasive procedure comprises a procedure wherein a smallersurgical incision is employed as compared to the size of the incisionrequired for conventional invasive surgery, for example, arthroscopicprocedures. Moreover, minimally invasive procedures minimize oreliminate the need for excessive retraction of a patient's tissues suchas muscles and nerves, thereby minimizing trauma and injury to themuscles and nerves and further reducing the patient's recovery time.

As the positioning component 108 is rotated causing the extending blocks110 and 112 to move closer to the ends of the respective screws 102 and104, the extending blocks 110 and 112 push the tabs 130 outward causingthe tabs 130 to assert pressure against surrounding bones and securingthe bone fusion device 100 in place. When the extending blocks 110 and112 reach as close to the end of the positioning components 108 asallowed, the tabs 130 are fully extended. Furthermore, since theextending blocks 110 and 112 travel along the positioning components108, along the threads of the screws 102 and 104, very precise positionsof the tabs 130 are able to be achieved. The tabs 130 are able to haveserrated edges or teeth 136 to further increase the bone fusion device'sgripping ability and therefore ability to be secured in place betweenthe bones for both a long-term purchase and a short-term purchase. Insome embodiments, the serrated edges or teeth 136 are able to be in atriangular or form a triangular wave formation as shown in FIG. 3.Alternatively, the serrated edges or teeth 136 are able to be filleted,chamfered, or comprise other teeth shapes or edge waves as are wellknown in the art. In some embodiments, the device 100 is able tocomprise a position locking mechanism that helps prevent the positioningcomponent 108 from slipping. In particular, the locking mechanism isable to be substantially similar to those described in U.S. patentapplication Ser. No. 14/210,094, filed on Mar. 13, 2014 and entitled“BODILESS BONE FUSION DEVICE, APPARATUS AND METHOD,” which is herebyincorporated by reference. In some embodiments, the locking mechanism isable to be positioned within a side wall of the frame 114 around thearound the positioning aperture 134 instead of being within a supportpanel of the device 100.

To secure the bone fusion device 100 in place, a user generally utilizesan insertion instrument such as a screw driver to turn the positioningcomponents 108. Screw drivers unfortunately have the ability to slip outof place. When performing surgery near someone's spine, it is preferableto prevent or at least minimize the slipping ability. Further, it isnecessary to ensure that the surgeon is able to precisely place andcontrol the device via a robust connection to the device. To do so,channels 122 having gripping apertures 128 are implemented to receivegripping fingers of a tool/insertion instrument (not shown) such thatthe tool cannot slip out of place during operation. Specifically, thechannels 122 are sized to receive the fingers to prevent the tool frommoving laterally with respect to the head of the positioning components108 and the gripping apertures 128 are sized to receive the fingertipsof the fingers of the tool such that the fingers (and tool) are unableto unintentionally be pulled out of the channels 122 (and positioningcomponents 108). In some embodiments, the channels 122 are aligned suchthat they are at the same height on opposite sides of the frame 114 ofthe device 100. Alternatively, the channels 122 are able to be offset(e.g. not at the same height). Alternatively, the channels 122 are ableto positioned on other portions of the frame 114. In operation, asurgeon causes the fingers of the tool to spread as the are insertedinto the channels 122, and then the surgeon causes the fingers to clamptogether inserting the fingertips of the fingers into the grippingapertures 128 and fully securing the tool onto the device 100. Thus, thetool is unable to slip out of place and is only able to be removed uponthe spreading of the fingers such that the fingertips are removed fromthe apertures 128 and the fingers are removed from the channels 122.Furthermore, if the device 100 is next to relatively immovable tissue(e.g. bone, ligament or tendon under load), then this device 100 willstill be able to disengage, whereas one that relies on clamping bybending two rods together will not work if one of the rods is restrictedby the relatively immovable tissue.

FIG. 2 illustrates a side perspective view of the bone fusion device 100according to some embodiments. The bone fusion device 100 utilizes thepositioning components 108 comprising the first screw 102 and the secondscrew 104 to move the first extending block 110 and the second extendingblock 112 outwardly from the middle of the bone fusion device 100towards its ends. The positioning component 108 is held in place butpermitted to turn utilizing one or more first pins 116. The one or morefirst pins 116 are secured within a retaining groove 106 (FIG. 3) of thepositioning component 108. The extending blocks 110 and 112 force thetabs 130 to either extend or retract depending on where the extendingblocks 110 and 112 are positioned. As described above, the tabs 130 areable to have serrated edges or teeth 136 to further increase grippingability. The tabs 130 are each coupled to the frame 114 of the bonefusion device 100 by one or more pin slots 132 (FIGS. 3 and 4A) and oneor more second pins 118 wherein the one or more second pins 118 fitwithin the one or more pin slots 132 and are able to travel along theinterior of the one or more pin slots 132. In some embodiments, each tab130 is secured with a single second pin 118 and pin slot 132.Alternatively, one or more of the tabs 130 are able to have multiplesecond pins 118 and pin slots 132. In some embodiments, the multiple pinslots 132 are able to be positioned at the corners of the tabs 130similar to the single pin slot 132 shown in FIG. 3. In some embodiments,the multiple pin slots 132 of tabs 130 are symmetric such that any tab130 is able to be placed on the top or bottom of the bone fusion device100. Alternatively, the pin slots 132 of the tabs 130 are able to bepositioned anywhere on the tab 130 and/or be positioned asymmetrically.In some embodiments, the pins/pin slots 118/132 are able to be replacedby or supplemented with one or more biasing elements positioned withinbiasing channels within the tabs 130 and/or frame 114 and therebybiasing the tabs 130 in the retracted position. In particular, thechannels and/or biasing elements are able to be substantially similar tothose described in U.S. patent application Ser. No. 14/210,094, filed onMar. 13, 2014 and entitled “BODILESS BONE FUSION DEVICE, APPARATUS ANDMETHOD.”

The holes/conduits 120 within the tabs 130 allow the bone graft materialto contact the vertebral bone after the device 100 has been insertedbetween the vertebrae of the patient. A set of holes/conduits 120 withinthe frame 114 also allow bone graft material to be inserted within thebone fusion device 100 after the bone fusion device 100 has been placed.Specifically, as shown in FIG. 2, the side of the frame 114 has anelongated hole 120 exposing the positioning component 108 and extendingblocks 112/110. This elongated hole 120 is able to serve as a channelfor pushing bone graft material into the frame 114 once it is inposition. In some embodiments, there is a matching elongated hole 120 onthe opposite side of the frame 114 such that the bone graft material isable to be added from either side using the hole 120 on that side. Insome embodiments, the channels 122 have gripping apertures 128implemented to receive a tool. Alternatively, the gripping apertures 128are able to be omitted.

FIG. 3 illustrates a cross-sectional view of components of the bonefusion device 100 according to some embodiments. As described above, thepositioning component 108 comprises a first screw 102 and a second screw104 wherein the first screw 102 is threaded differently than that of thesecond screw 104. Furthermore, the first screw 102 is of a slightlydifferent size than the second screw 104. For example, in someembodiments the first screw 102 is an 8-32 screw and the second screw isa 6-32 screw. A retaining groove 106 is utilized to secure thepositioning component 108 in place. In some embodiments, the retaininggroove 106 is positioned opposite the end of the positioning component108 having the positioning aperture 134. To ensure that the tool doesnot slip while turning the positioning component 108, the channels 122having fingertip gripping apertures 128 are utilized to secure the toolas described above. Alternatively, the fingertip gripping apertures 128are able to be omitted and the channels 122 are able to secure the toolas described above. A first extending block 110 and a second extendingblock 112 are utilized with the positioning component 108 to extend andcompact one or more of tabs 130. The first extending block 110 has aninternal opening and threading to fit around the first screw 102. Thesecond extending block 112 has an internal opening and threading to fitaround the second screw 104. As described above, the frame 114 of thebone fusion device 100 contains a set of holes/conduits 120 within theframe 114 for allowing bone graft material to be inserted. Furthermore,one or more first pins 116 secure the positioning component within theframe 114. One or more second pins 116 in conjunction with one or morepin slots 132 secure the tabs 130 to the frame 114.

FIG. 4A illustrates a cross sectional view of the bone fusion device 100with the tabs retracted according to some embodiments. When theextending blocks 110 and 112 are positioned in the middle of thepositioning component 108 with the first screw 102 and the second screw104, the tabs 130 are positioned within the frame 114 of the bone fusiondevice 100 with the central ribs 124 slid within the rib slots 126. Theretaining groove 106 holds the positioning component 108 in place withone or more first pins 116. The tabs 130 are coupled to the frame 114 ofthe bone fusion device 100 using the one or more slots 132 and the oneor more second pins 118 wherein the one or more second pins 118 fitwithin the one or more slots 132 and are able to travel/slide along theinterior of the one or more slots 132.

FIG. 4B illustrates a cross sectional view of the bone fusion device 100with the tabs extended according to some embodiments. As shown in FIG.4A, the bone fusion device 100 is compressed/contracted when theextending blocks 110 and 112 are in the middle of the bone fusion device100. As a user turns the positioning component 108 via the positioningaperture 134, the extending blocks 110 and 112 gradually move outwardfrom the middle. If the user turns the positioning component 108 in theopposite direction, the extending blocks move back towards the middle.As the extending blocks 110 and 112 are moving outward, the central ribs124 slide out of the rib slots 126 and the extending blocks 110, 112push on the tabs 130. Alternatively, the central ribs 124 and/or ribslots 126 are able to be configured such that the central ribs 124 arefully within the rib slots 126, fully removed from the rib slots 126, orsomewhere in between at any point along the path of the extending blocks110, 112 from the center of the device to the ends of the device. Thetabs 130 extend because the extending blocks 110 and 112 exert forceagainst the angled tabs 130 outwardly as shown by the arrows 140. Whenthe extending blocks 110 and 112 are positioned near the ends of thebone fusion device 100, the tabs 130 extend beyond the frame 114 of thebone fusion device 100 and ultimately secure the bone fusion device 100between two bones. With the tabs 130 coupled to the frame 114 of thebone fusion device 100 by the one or more slots 132 and the one or moresecond pins 118, the tabs 130 are able to extend beyond the frame 114 ofthe bone fusion device 100 as the one or more second pins 118 travelwithin the interior of the one or more slots 132.

In operation, the bone fusion device 100 is initially configured in acompact position such that the extending blocks 110, 112 are located inthe middle of the bone fusion device 100 thereby allowing the tabs 130to rest within the frame 114 of the bone fusion device 100. The compactbone fusion device 100 is then inserted into position within thepatient. The surgeon is able to then the expand the bone fusion device100 by rotating the positioning component 108 which moves the extendingblocks 110, 112 towards the opposing ends of the bone fusion device100—one near the head of the positioning component 108 and the othertowards the tail of the positioning component. As the extending blocks110, 112 move away from the middle, the tabs 130 are pushed outwardlyfrom the pressure of the extending blocks 110, 112 against the angledtabs 130. Initially, the central ribs 124 of the tabs 130 remain atleast partially within the rib slots 126 of the extending blocks 110,112 such that the blocks 110, 112 are able to resist torsional forces onthe tabs 130 and/or device 100. Gradually, the central ribs 124 slideout of the rib slots 126 as the extending blocks 110, 112 approach theends of the positioning component 108. Alternatively, the central ribs124 are able to be configured such that they remain at least partiallywithin the rib slots 126 as the extending blocks 110, 112 approach theends of the positioning component 108. Eventually the extending blocks110, 112 exert a satisfactory force between the extended tabs 130 andthe bones to be fused. At that point the bone fusion device 100 is ableto remain in place. Thereafter, material for fusing the bones together(e.g. bone graft material) is inserted through the holes and openings120 within the bone fusion device 100. Alternatively, the insertion ofthe material for fusing the bones together is able to be omitted.

FIG. 5 illustrates a bone fusion device 500 having a single tabextension/retraction mechanism according to some embodiments. The bonefusion device 500 shown in FIG. 5 is substantially similar to the bonefusion device 100 except for the differences described herein. Inparticular, the bone fusion device 500 comprises a half frame 514, oneor more half extending blocks 510, 512, a tab 530 and positioningcomponent 508. Similar to the bone fusion device 100, the half extendingblocks 510, 512 are coupled around the positioning component 508 suchthat when the positioning components 508 are turned, the blocks 510, 512move outwards causing the tab 530 to move to the extended position. Thehalf frame 514 comprises a tab aperture (see FIG. 1A) for receiving thetab 530 and a solid floor 538 opposite the tab aperture. In someembodiments, the floor 538 is able to have one or more floorholes/conduits for receiving/distributing grafting material into and outof the device 500. In some embodiments, the device 500 is sized suchthat when the tab 530 is in the compact/retracted position the distancebetween the top of the tab 530 and the floor 538 is less than or equalto 5 mm, and when the tab 530 is in the extended position the distancebetween the top of the tab 530 and the floor 538 is less than or equalto 7 mm. Alternatively, the device 500 is sized such that when the tab530 is in the compact/retracted position the distance between the top ofthe tab 530 and the floor 538 is in the range of 5 mm to 13 mm and whenthe tab 530 is in the extended position the distance between the top ofthe tab 530 and the floor 538 is in the range of 7 mm to 22 mm.Alternatively, other sizes of the device 500 are contemplated as arewell known in the art. Thus, by including only a single tab 530, theheight of the device 500 is able to be minimized. As a result, the bonefusion device 500 enables surgeons to use smaller incisions as well asto fit the bone fusion device 500 into smaller places and increasing theversatility of the device 500. Additionally, it should be noted that thesingle tab extension/retraction mechanism described in FIG. 5 is able toreplace each of the dual or multiple tab extension/retraction mechanismsdescribed herein wherein the devices having dual tabextension/retraction mechanisms are essentially halved (except for thepositioning component) such that only one tab is remaining.

FIGS. 6A and 6B illustrate a front and a side view of a bone fusiondevice 600 having one or more protruding tabs according to someembodiments. The bone fusion device 600 shown in FIGS. 6A and 6B issubstantially similar to the bone fusion device 100 except for thedifferences described herein. In particular, the bone fusion device 600comprises one or more tabs 630 having a height such that even when fullyretracted an outer end or surface 602 of the tabs 630 extends beyond theplane or face of the frame 614. For example, the outer end or surface602 is able to comprise the outwardly pointing teeth 636 and/or othermost outward portions of the tabs 630. As a result, when placed betweentwo bones (e.g. vertebra) before being extended, the teeth 636 or otherportions of the surface 602 of the bottom facing tab 630 are able toprovide traction with the bone surface such that the device 600 does notslip out of place when the tabs 630 are being extended. In someembodiments, only one of the tabs 630 extends beyond the face of theframe 614 in the fully retracted position. Alternatively, two or more ofthe tabs 630 (e.g. all of the tabs) extend beyond the face of the frame614 in the fully retracted position. In some embodiments, only a portion(not the full length) of the outward face or end 602 of the tabs 630extend beyond the face of the frame 614 in the fully retracted position.Alternatively, the full length of the outward face or end 602 of thetabs 630 is able to extend beyond the face of the frame 614 in the fullyretracted position. In some embodiments, the tabs 630 extend 0.25millimeters beyond the face of the frame 614 in the fully retractedposition. Alternatively, one or more of the tabs 630 are able to extendmore or less than 0.25 millimeters (e.g. 0.1 mm) beyond the face of theframe 614 in the fully retracted position. Additionally, although asshown in FIGS. 6A and 6B the device 600 comprises two tabs 630 and allof the tabs 630 have ends 602 that extend beyond the face of the frame614 in the fully retracted position, the device 600 is able to compriseany number of tabs 630 (e.g. one or more) wherein one or any combinationof a plurality of the tabs 630 are able to have ends 602 that extendbeyond the face of the frame 614 in the fully retracted position.Further, as described above, one or more of the components of the bonefusion device 600 are able to be incorporated into one or more of theother embodiments of bone fusion devices described herein.

FIGS. 7A-7C illustrate a front, side and top view of a bone fusiondevice 700 having one or more protruding rails according to someembodiments. The bone fusion device 700 shown in FIGS. 7A-7C issubstantially similar to the one or more of the other embodiments ofbone fusion devices (e.g. bone fusion device 100) except for thedifferences described herein. In particular, the bone fusion device 700comprises one or more rails 702 adjacent to one or more of the tabs 730that protrude above the plane or face of the frame 714. For example, asshown in FIGS. 7A-7C, two rails 702 are positioned next to oppositesides/edges of each of the tabs 730. As a result, the rails 702 providethe advantage of preventing a protruding portion of one or more of thetabs 730 or other parts of the device 700 from catching on anythingduring insertion of the device 700 into position. In some embodiments,the rails 702 are utilized in conjunction with protruding tabs 630 asshown in FIGS. 6A and 6B. Alternatively, the rails 702 are able to beused in conjunction with protruding tabs, non-protruding tabs, othertypes of tabs described herein and/or any combination thereof. In someembodiments and as shown in FIGS. 7A-7C, the rails 702 only extend alonga portion (not the entire length) of an edge of the perimeter of one ormore of the tabs 730. As a result, those portions of the edges of theperimeter of the one or more of the tabs 730 will be guarded by therails 702 whereas the remainder of the edges will not be guarded. Inparticular, if the tabs 730 are protruding tabs 630, despite protrudingbeyond the frame 714, as described above, the guarded portion of theends 602 of the protruding tabs 630 will still be adjacent to the rails702 whereas the unguarded portion of the ends 602 will extend beyond theface of the frame 714 without any adjacent rails 702.

In some embodiments, one or more of the rails 702 are able to havelength such that they extend the full length of a side or sides of theperimeter of one of the tabs 730. For example, a rail 702 is able toform a ring such that it extends the entire perimeter of one of the tabs730. As another example, one or more rails 702 are able to extend aroundthe corners created by two or more of the sides of the perimeter of oneof the tabs 730. In such embodiments, the rails 702 are able to makeperpendicular and/or rounded turns in order to wrap around the multiplesides. Alternatively or in addition, one or more of the rails 702 areable to have length such that they do not extend the full length of aside or sides of the perimeter of one of the tabs 730 and/or one or moreof the rails 702 are able to be discontinuous such that there are gapsbetween one or more portions of the one or more of the rails 702. Insome embodiments, a plurality of rails 702 are able to be next to thesame side of the perimeter of one of the tabs 730. In other words, twoor more rails 702 next to the same side are able to be the same ordifferent lengths and/or be aligned or otherwise overlap in the portionsof the perimeter of the tab 730 that they are next to. In someembodiments, the positioning of the rails 702 next to the tabs 730 isbiased toward the front of the device 700 (e.g. away from the side wherethe positioning component is accessible). For example, as shown in FIGS.7A-7C, the rails 702 start at the front leading edge of the tabs 730such that when the device 700 is inserted frontwards the rails willguard the front leading edge of the tabs 730 from getting caught duringthe insertion.

In some embodiments, a portion or all of one or more of the rails 702are able to directly abut the edge of the tabs 730. Alternatively or inaddition, a portion or all of one or more of the rails 702 is able to bespaced away from the edges of the tab 702 somewhere along the side ofthe frame 714 from which the tab 702 is able to extend. In someembodiments, one or more of the rails 702 form lines that are parallelor non-parallel with the closest edge of the tab 730. Alternatively, oneor more of the rails 702 are able to be partially or wholly non-linear(e.g curved). In some embodiments, the rails 702 are positioned inmatching or mirroring pairs around one or more of the tabs 730. Forexample, as shown in FIGS. 7A-C each of the tabs 730 have a pair ofmatching rails 702 that straddle the tab 730 along a portion of thelonger edges of the perimeter of the tab 702, wherein the portion is thepart of the longer edges closest to the front of the device 700.Alternatively, the one or more rails 702 next to a tab 730 are able tobe asymmetric.

In some embodiments, one or more of the rails 702 are coupled to thesides of the frame 714 next to the tabs 730. Alternatively or inaddition, one or more of the rails 702 are able to be integrated intothe frame 714 itself (e.g a protrusion of the frame 714 itself). In someembodiments, one or more of the rails 702 extend 0.25 millimeters beyondthe face of the frame 714 in the fully retracted position.Alternatively, one or more of the rails 702 are able to extend more orless than 0.25 millimeters (e.g. 0.1 mm) beyond the face of the frame714 in the fully retracted position. Indeed, one or more of the rails702 are able to be positioned anywhere along the perimeter of one ormore of the tabs 730, wherein the perimeter includes the side, plane orface of the frame 714 that surrounds the outwardly facing face of thetabs 730. Additionally, as described above, one or more of thecomponents of the bone fusion device 700 are able to be incorporatedinto one or more of the other embodiments of bone fusion devicesdescribed herein.

Insertion Apparatus

FIG. 8 illustrates a bone fusion device insertion apparatus 800according to some embodiments. As shown in FIG. 8, the bone fusionapparatus 800 comprises a bone fusion insertion instrument 802detachably coupled to a bone fusion device 804 via a coupling mechanism806. In some embodiments, the bone fusion device 804 is substantiallysimilar to the bone fusion device 100 described in FIGS. 1-7.Alternatively, the bone fusion device 804 is able to be otherembodiments of bone fusion devices described herein or other types ofbone fusion devices as are well known in the art. In some embodiments,the other types of bone fusion devices are able to be formed by one ormore of polymers, bone, synthetic bone, metal or other biocompatiblematerials as are well known in the art. In some embodiments, thecoupling mechanism 806 comprises a clamping mechanism. Alternatively,the coupling mechanism 806 is able to comprise any combination of aclamps, screws, locks, adhesives or other attachment elements as arewell known in the art. In some embodiments, the insertion instrument 802is able to detachably couple to a plurality of bone fusion devices 804simultaneously such that the plurality of devices 804 are able to besimultaneously controlled (e.g. extension/contraction of the tabs) bythe single insertion instrument 802.

FIG. 9A illustrates a side view of the insertion instrument 802according to some embodiments. FIG. 9B illustrates a sidecross-sectional view of the insertion instrument 802 according to someembodiments. FIG. 9C illustrates a perspective exploded view of theinsertion instrument 802 according to some embodiments. As shown in FIG.9A, the insertion instrument 802 comprises a body portion 904 includinga housing tube 906, a clamping sleeve 908, one or more channel knobs910, a handle 916 and an end cap 914, and a head portion 902 including aplurality of clamping fingers 903 and a spreading rod 901 operablycoupled within the head portion 902 of the housing tube 906. In someembodiments, the head portion 902 is sized such that the cross-sectionof the head 902 is smaller than the cross section of the bone fusiondevice 100. As shown in FIG. 9B, the spreading rod 901 is positionedwithin the head portion 902 of the housing tube 906 between the clampingfingers 903, which extend from a finger tube 905 that is positionedwithin a hollow cavity of the body portion 904 of the housing tube 906.Specifically, the spreading rod 901 is fixed in position relative to thehousing tube 906. As a result, when the finger tube 905 is slide furtherout of the head 902 of the tube 906, the fingers 903 are forced furtherapart by the rod 901 until they are in a spread position as shown inFIG. 10A, and when the finger tube 905 is slide back into the head 902of the tube 906, the fingers 903 are able to move closer together to aclosed position as shown in FIG. 10B. In the spread position, thefingers 903 are separated by a distance greater than the distancebetween the surface of the gripping apertures 128 and/or the channels122 having the gripping apertures 128. In the closed position, thefingers 903 are separated by a distance equal to or less than thedistance between the surface of the gripping apertures 128 and/or thechannels 122 having the gripping apertures 128. Thus, when in the closedposition, the fingers 903 are able to enter the gripping apertures 128and secure the coupling mechanism 806 to the bone fusion device 804, andwhen in the spread position, the fingers 903 are able to be removed fromthe gripping apertures 128 thereby releasing the coupling mechanism 806from the device 804.

In some embodiments, the fingers 903 are biased toward the closedposition such that when not forced apart by the rod 901 the fingers 903automatically spring back to the closed position. Alternatively, thefingers 903 are able to not be biased and the walls of the head portion902 of the housing tube 906 are able to push the fingers 903 back intothe closed position as they are pulled back into the head 902.Alternatively, as shown in FIGS. 10C and 10D, the fingers 903 are ableto be biased in the spread position such that when not forced togetherby the walls of the head 902 of the housing tube 906 the fingers 903automatically spring to the spread position. In particular, in suchembodiments the spreading rod 901 is able to be omitted. As also shownin FIG. 9B, the end cap 914 is threaded or screwed into the end of thehousing tube 906 and the handle 916 is threaded or screwed into the sideof the housing tube 906 via a threaded connection member 917 such thatthe handle is perpendicular or substantially perpendicular to a centralaxis 900 of the instrument 802 (as shown in FIG. 9C). The end cap 914 isable to be tubular with a round or circular exterior surface tofacilitate the screwing and threadable coupling. However, a back end ofthe end cap 914 is able to have one or more cutouts such that instead ofbeing circular, a cross section of the back end of the end cap 914 thatis perpendicular to the central axis 900 will be non-circular. Forexample, as shown in FIGS. 9A-C, the top and bottom of the back end arecutout such that the cross-section is a partial circle minus portionsabove a top secant line and a bottom secant line. Alternatively, anyother cutouts are able to be used that produce non-circularcross-sections. In particular, as described in detail below, thenon-circular cross-section enables a measuring tool 1100 to slide ontothe back end of the end cap 914, wherein the non-circular cross-sectionprevents the measuring tool 1100 from being able to rotate about theback end when coupled.

Further, an end tube 912 and the channel knobs 910 are able to becoupled to the end of the finger tube 905. In some embodiments, the endtube 912 and/or channel knobs 910 are able to be integrated into thefinger tube 904. Alternatively, the end tube 912 is able to be omitted.The control sleeve 908 is threaded or screwed onto the outside of thehousing tube 906 such that, when rotated in a first direction about thethreading, the control sleeve 908 moves toward the head 902 and, whenrotated in the opposite direction about the threading, the controlsleeve 908 moves toward the opposite end of the instrument 802 near theend cap 914. Further, the inner surface of the sleeve 908 has an annularchannel 909 configured for receiving the ends of the channel knobs 910through one or more corresponding sliding apertures 918 within thehousing tube 906. Specifically, the channel knobs 910 are able to extendfrom the end tube 912 and/or finger tube 905 through the slidingapertures 918 and at least partially into the channel 909 of the sleeve908. As a result, when the sleeve 908 moves toward or away from the head902 (via rotation about the threading), the position of the knobs 910 inthe channel 909 causes the knobs 910 to be pushed/pulled by the sleeve908 and thereby correspondingly move the finger tube 905 toward or awayfrom the head 902 which, as described above, causes the fingers 903 tomove between the spread and closed positions. The edges of the slidingapertures 918 are able to limit the extent to which the knobs 910 areable to slide and thereby prevent the fingers 903 from being spread toofar apart or pulled too far into the tube 906. Accordingly, a user isable to controllably move the fingers 903 between the spread and closedpositions by selectively rotating the sleeve 908 between a closed andopen (or spread) position. Although as shown in FIGS. 9A-C, theinstrument 802 includes two knobs 910 positioned through two separateapertures 918, more or less knobs 910 and/or apertures 918 are able tobe used.

In some embodiments, the instrument 802 further comprises a centralhollow channel that extends through the length of the instrument 802along an axis 900 from the end of the head 902 to the end of the body904 at the end cap 914 as shown in FIG. 9C. Specifically, each of thecomponents of the instrument 802 that cross the axis 900 (e.g. fingertube 905, end cap 914, spreading rod 901) are able to have an aperture,channel or through-hole that aligns with the axis 900 such that togethereach of the components form the central hollow channel of the instrument802. As a result, as discussed in detail below, a docking rod 1506and/or a bone fusion device engaging tool 1200 (e.g. a screw driver rod)is able to be selectively removed or positioned through the centralhollow channel in order to access the positioning aperture 134 of a bonefusion device 100 coupled to the instrument 802 by the fingers 903.

Measurement Apparatus

FIGS. 11A-11D illustrate perspective, top, front and back views,respectively, of a measuring tool 1100 according to some embodiments.Specifically, as shown in FIGS. 11A-11D, the measuring tool 1100comprises an indicator body 1102 and a coupling cap 1104. The indicatorbody 1102 comprises a screw 1110, a viewing aperture 1113, an indicatorring 114, a height line 1115, height markings 116 and a support bridge1118. The coupling cap 1104 comprises a coupling aperture 1106, aperturebracers 1107, a gear wheel 1108 having perimeter teeth 1109, a screwgear 1111 and a compatibility marker 1112. Alternatively, one or more ofthe components of the cap 1104 and/or the body 1102 are able to beomitted.

The indicator ring 1114 is threaded and screwed onto the screw 1110 andboth are positioned within the body 1102. In some embodiments, the ring1114 protrudes at least partially into the viewing aperture 1113. Theheight markings 1116 are positioned along the perimeter of at least aportion of the viewing aperture 1113, which extends vertically along aside of the body 1102. As a result, the ring 1114 is exposed or visiblewithin the body 1102 when it is positioned on the screw 1110 adjacent toone or more of the height markings 1116. The screw 1110 is pivotably orrotatably coupled within the body 1102 and the ring 1114 is slidablycoupled within the body 1102 such that the screw 1110 is able to rotateabout its axis within the body 1102 causing the ring 1114 to slide up ordown the screw 1110 along the viewing aperture 1113 depending on thedirection of rotation. In some embodiments, the ring 1114 is preventedfrom rotating with the screw 1110 due to its protrusion into the viewingaperture 1113. As a result, the rotation of the screw 1110 causes thering 1114 and its height line 1115 to move with respect to heightmarkings 1116 (along the axis of the screw 1110) and thus sometimesalign with the height markings 1116.

On the surface of the cap 1104, the compatibility marker 1112 indicatesone or more bone fusion devices 804 with which the measuring instrument802 is compatible. Specifically, in this context compatible means thatthe markings 1116 and/or the screw 1110/ring 1114 threading granularityare proportional to the rate of extension of the tabs of the indicatedcompatible bone fusion devices 804 indicated by the marker 1112. Inother words, the instrument 1100 is compatible with a bone fusion device802 if the amount of the extension of the tabs of the device 804 isaccurately indicated by the alignment of the markings 1116 and theheight line 1115 of the ring 1114 when the instrument 1100 is used inconcert with the extension/retraction of the tabs as described in detailbelow.

Within the cap 1104, the gear wheel 1108 is rotatably coupled about thecoupling aperture 1106 and has both inner gear teeth 1109 a and outergear teeth 1109 b, wherein at least the inner gear teeth 1109 a areexposed/accessible from the exterior of the cap 1104 about the aperture1106. Similarly, the screw gear 1111 is fixedly coupled to the screw1110, but rotatably coupled within the cap 1104 about the axis of thescrew 1111 such that the screw 1110 and the screw gear 1111 together areable to rotate within the cap 1102 and body 1104 about the axis of thescrew 1110. The outer gear teeth 1109 b of the gear wheel 1108 areengaged with the gear teeth of the screw gear 1111. Consequently, therotation of the screw 1110 is able to be caused by rotating the gearwheel 1108 (e.g. via the inner gear teeth 1109 a) which in turn rotatesthe screw gear 1111 coupled to the screw 1110. Therefore, movement ofthe ring 1114 with respect to the markings 1116, the screw 1110 and/orthe aperture 1113 is proportional to and based on the rotation of gearwheel 1108 and/or the corresponding rotation of the screw/screw gear1110, 1111.

As shown in FIG. 13, the coupling aperture 1106 is defined by theaperture bracers 1107 such that the back end of the end cap 914 of theinsertion instrument 802 is able to fit in between the bracers 1107within the aperture 1106. In particular, the aperture 1106 as defined bythe bracers 1107 is able to have a non-circular cross-section thatmatches the cross-section of the back end of the end cap 914 in order toenable the end cap 914 to slide into the aperture 1106 but not rotatewithin the aperture 1106. As a result, the coupling aperture 1106enables the measuring tool 1100 to detachably couple to the insertioninstrument 802. Further, because of the position of the end cap 914,when coupled to the insertion instrument 802 the aperture 1106 and/orthe gear wheel 1108 are centered about the central axis 900 and/or thecentral hollow channel of the insertion instrument 802. In particular,as described in detail below, this enables the engaging tool 1200 (FIG.12) to align with the aperture 1106 and/or the gear wheel 1108 when slidthrough the aperture 1106 into the central hollow channel of theinsertion instrument 802 for engaging the bone fusion device 804.Additionally, the support bridge 1118 is sized and contoured to matchand contact the outer surface of the insertion instrument 802 when themeasuring tool 1100 and the insertion instrument 802 are coupledtogether in order to prevent the body 1102 from bending the cap 1104toward the instrument 802. Alternatively, the support bridge 1118 isable to be omitted.

FIGS. 11E-11H illustrate perspective, top, front and back views,respectively, of an alternate embodiment of the measuring tool 1100′according to some embodiments. The measuring tool 1100′ shown in FIGS.11E-11H is able to be the substantially same as the measuring tool 1100shown in FIGS. 11A-11D except for the differences described herein.Specifically, the measuring tool 1100′ comprises an indicator body 1102having a protruding neck 1101 that provides further support for the cap914 when inserted into the coupling aperture 1116, wherein the supportbridge 1118 is omitted. Additionally, the body 1102 is able to include aplurality of viewing apertures 1113. In some embodiments, there arethree viewing apertures 1113. One aperture 1113 on the end of the body1102, as shown in FIG. 11F, and two on either side of the body 1102 (oneis shown in FIG. 11E and the other is hidden on the opposite side). As aresult, the tool 1100′ is able to be read from any of the three sides.

Further, each viewing aperture 1113 is able to have a corresponding setof markings 1116 and/or two or more of the viewing apertures 1113 areable to share a set of markings 1116. For example, as shown in FIG. 11E,a set of markings 1116 is able to be positioned in between two of theapertures 1113 such that the lines of the markings are able to be read(e.g. extend to) both of the apertures 1113.

FIG. 12 illustrates a bone fusion device engaging tool 1200 according tosome embodiments. As shown in FIG. 12, the tool 1200 comprises a handle1202 coupled to an elongated member or rod 1204 having an engaging tip1206 and an interface gear 1208 coupled to the base of the handle 1202centered around the member 1204. The elongated member 1204 is able to betubular and/or sized to slide and rotate within the central hollowchannel of the insertion instrument 802 along the axis 900. The tip 1206is able to be configured (e.g. contoured) to operably fit within orotherwise interface with the positioning aperture 134 of the device 804such that when positioned within the aperture 134, rotation of the tip1206 causes the positioning component 108 to correspondingly rotate. Forexample, the tip 1206 is able to have a hexagonal shape, a star-shape, aflat-head shape, a Philips head shape or other types of bit shapes asare known in the art. The teeth of the interface gear 1208 are able tobe configured to operably engage with the inner teeth 1109 a of the gearwheel 1108. Further, as shown in FIG. 13, when fully slid into thecentral hollow channel of the insertion instrument 802 after themeasuring tool 1100 is positioned on the end of the end cap 914 (e.g.through the coupling aperture 1106), the teeth of the interface gear1208 operably engage with the inner teeth 1109 a of the wheel gear 1108.As a result, rotation of the engaging tool 1200 causes the wheel gear1108 to correspondingly rotate, which as described above moves theindicator ring 1114 up and down the screw 1110. Similarly as shown inFIG. 13, the elongated member 1204 is able to have a length such thatwhen fully slid into the central hollow channel of the insertioninstrument 802, the tip 1206 extends into the positioning aperture 134when the device 100/804 is coupled to the insertion instrument 802.Accordingly, when operably coupled, rotation of the engaging tool 1200simultaneously extends/retracts the tabs 130 of the coupled device100/804 and moves the indicator ring 1114 with respect to the markings1116.

FIG. 13 illustrates a bone fusion device insertion and measuring system1300 according to some embodiments. As shown in FIG. 13, the system 1300has the engaging tool 1200 and the measuring tool 1100 both operablycoupled with the insertion instrument 802, with the bone fusion device100/804 also being coupled to the instrument 802. As further shown inFIG. 13 and described above, when the device 100/804 is grasped by thecoupling mechanism 806 in the closed position, the tabs 130 are able tobe selectively extended or retracted by rotating the engaging tool 1200with respect to the instrument 802 and/or device 100/804 as the tip 1206is engaged within the positioning aperture 134. At the same time, therotation of the engaging tool 1200 is able to move the indicator ring1114 of the measuring tool 1100 with respect to the markings 1116 viathe engagement of the interface gear 1208 and the gear wheel 1108,wherein the movement of the indicator ring 1114 is proportional to theamount of extension of the tabs 130 such that its alignment with themarkings 1116 indicates the current amount of extension of the tabs 130.Consequently, the engaging tool 1200, measuring tool 1100, device100/804 and/or insertion instrument 802 provide the advantage ofenabling a user to control and determine a current amount that the tabs130 are extended by observing the alignment of the height line 1115 withthe markings 1116. Additionally, the removability of the engaging tool1200 from the insertion instrument 802 beneficially enables theinsertion instrument 802 to be used in concert with other tools or rodsby simply removing the engaging tool 1200 when no longer needed.Similarly, the removability of the measuring tool 1100 enables differentdevices 100/804 having different sizes and/or rates of tab 130 extensionto be used with the same insertion instrument 802 by simply replacingcurrent measuring tool 1100 (having a first compatibilty marker 1112that does not correspond to the desired device 100/804) with a differentmeasuring tool 1100 having a compatibility marker 1112 that correspondsto the desired device 100/804.

A method of operation of the bone fusion system 1300 according to someembodiments will now be discussed in conjunction with the flow chartshown in FIG. 14. A user couples the measuring tool 1100 with theinsertion instrument 802 by sliding the coupling aperture 1106 onto theend cap 914 at the step 1402. In some embodiments, step 1402 comprisesselecting the measuring tool 1100 from a plurality of measuring tools1100 each having a compatibility marker 1112 based on which of the tools1100 has compatibility markers 1112 that corresponds to the desired bonefusion device 100/804. A user couples the engaging tool 1200 with theinsertion instrument 802 and the measuring tool 1100 by sliding theengaging tool 1200 through the coupling aperture 1106 and/or into thecentral hollow channel of the insertion instrument 802 until theinterface gear 1208 engages with the gear wheel 1108 at the step 1404.Alternatively, step 1402 is able to occur after the device 100/804 hasbeen coupled to the insertion instrument 802 as described in step 1408.

A user causes the fingers 903 of the insertion instrument 802 to spreadby rotating the control sleeve 908 to an open or spread position at thestep 1406. The user slides the fingers 903 into the channels 122 of thebone fusion device 100/804 at the step 1408. The user causes the fingers903 to close by rotating the control sleeve 908 in the oppositedirection to a closed position such that the fingers 903 (or the tips ofthe fingers) slide into the gripping apertures 128 of the channels 122thereby detachably coupling the insertion instrument 802 to the bonefusion device 100/804 at the step 1410. The user moves the bone fusiondevice 100/804 into the desired position within the patient with theinsertion instrument 802 at the step 1412. In some embodiments, theinner cavity of the bone fusion device 100/804 is packed with a bonegraft material prior to being positioned within the patient. In someembodiments, the desired position comprises replacing a spinal disc withthe bone fusion device 804 in between two vertebrae. Alternatively, thedesired position is able to comprise replacing a degenerated vertebraewith the bone fusion device 100/804 in between the two adjacentvertebrae and/or spinal discs. Alternatively, the insertion instrument802 is able to be used to position other types of spinal devices such asa dynamic device, a total/partial artificial disc, a nucleus pulposus orother medical devices as are well known in the art. In some embodiments,the bone fusion device 100/804 is inserted anteriorly. Alternatively,the bone fusion device 100/804 is able to be inserted posteriorly,laterally or transforaminaly.

Once in place, the user rotates the engaging tool 1200 within theinsertion instrument 802 as it is engaged in the positioning aperture134 in order to extend the tabs 130 of the device 100/804 as desired atthe step 1414. The user observes the alignment of the height line 1115of the indicator ring 1114 with the height markings 1116 and stopsrotating the engaging tool 1200 when the height line 1115 is alignedwith the height marking 1116 indicating the desired height at the step1416. The user removes the engaging tool 1200 from within the insertioninstrument 802 at the step 1416. The user decouples the measurement tool1100 from the end cap 914 at the step 1418. Alternatively, themeasurement tool 1100 is able to remain on the end cap 914. As a result,the method of operating the bone fusion system 1300 enables the surgeonto securely position the bone fusion device 804 and extend the tabs 130as needed with minimal possibility of the drive mechanism slipping outof the positioning aperture 134. Specifically, by coupling the fingers903 within the gripping apertures 128 and the channels 122, theinsertion instrument 802 is prevented from being pulled, pushed ortwisted away from the bone fusion device 804. Thus, the procedure ismade both safer and more efficient. In some embodiments, the measurementtool 1100 is able to be omitted and the engaging tool 1200 is able to beused with the insertion instrument 802 without also coupling with themeasurement tool 1100.

Autograft Delivery Apparatus

FIG. 15 illustrates a bone fusion device system 1500 according to someembodiments. As shown in FIG. 15, the bone fusion system 1500 comprisesa bone fusion device 1504 and bone fusion delivery apparatus including adelivery member 1502, a docking rod 1506 and one or more plungers 1508.As shown in FIG. 15, the docking rod 1502 is able to detachably couplewith the bone fusion device 1504 and thereby facilitate the coupling orinterfacing of the delivery member 1502 and the bone fusion device 1504for delivery of the autograft or other material to the inside of thedevice 1504 via the delivery member 1502. Specifically, the deliverymember 1502 is able to slide onto and/or otherwise couple with thedocking rod 1506, wherein the member 1502 and rod 1506 are configuredsuch that, when the docking rod 1506 is coupled with the device 1504,coupling of the docking rod 1506 and the delivery member 1502 results inan coupling or interface alignment of the delivery member 1502 and thedevice 1504 (e.g. a channel 120 on the side of the device). The plungers1508 are then able to detachably coupled to and/or used with thedelivery member 1502 to force desired material through the deliverymember 1502 into the bone fusion device 1504. The system 1500 is able tobe combined with one or more of the components of the system 800described above in order to create an insertion, measurement and/ordelivery system. The bone fusion device 1504 is able to be substantiallysimilar to the bone fusion devices 100, 804 described above.Alternatively, the bone fusion device 1504 is able to be otherembodiments of bone fusion devices described herein or other types ofbone fusion devices as are well known in the art. In some embodiments,the other types of bone fusion devices are able to be formed by one ormore of polymers, bone, synthetic bone, metal or other biocompatiblematerials as are well known in the art.

FIGS. 16A-D illustrate a top, side cross-sectional, perspective andfront view, respectively, of the delivery member 1502 according to someembodiments. As shown in FIGS. 16A-D, the delivery member 1502 comprisesa delivery shaft 1602, a handle 1604 and a funnel 1606. The funnel 1606is able to be at least partially coupled within a back end of the handle1604 via one or more locking pins 1608. Alternatively, funnel 1606 isable to be integrated with the handle 1604 to form a single component orthe funnel 1606 is able to be coupled with the handle 1604 via othercoupling mechanisms as are well known in the art that replace orsupplement the pins 1608. The a portion of the delivery shaft 1602 isable to be coupled within or through a front end of the handle 1604 suchthat a tip of the funnel 1606 aligns with, couples to and/or abuts anentrance aperture of the delivery shaft 1602. The remainder of thedelivery shaft 1602 extends out from the front end of the handle 1604and ends at a exit aperture 1610. The back end of the funnel 1606 isable to have a threaded outer or inner surface and/or have a tubular orcircular shape such that one or more of the plungers 1508 are able tothreadably couple with the funnel 1606 via the threading.

As shown in FIGS. 16A-D, the exit aperture 1610 is able to be defined byan L-shaped cutout of the tip of the delivery shaft 1602. In particular,this L-shape enables exit aperture 1610 to fit against or contour to aleft or right front corner of the bone fusion device 1504 wherein thecorner of the L-cutout meets the left or right front corner of thedevice 1504 and the scoop-like portion of the exit aperture 1610 extendsalong the corresponding left or right side of the bone fusion device1504 (in order to align with one or more side channels 120).Alternatively, the exit aperture 1610 is able to comprise any othershapes that enable material to exit the tip of the shaft 1602. Indeed,in some embodiments the system 1500 is able to comprise two deliverymembers 1502, wherein the first member 1502 has an L-shaped exitaperture 1610 and the second member 1502 has a differently shaped exitaperture 1610 (e.g. an aperture created by a cross-section cut of theshaft 1602 orthogonal to the axis of the shaft 1602).

The delivery shaft 1602 is able to further comprise one or more couplinghoops 1612 that extend from the outer surface of the delivery shaft1602. Specifically, each of the coupling hoops 1612 are able to bealigned such that their respective through-holes are aligned along asingle axis. As a result, the coupling hoops 1612 enable the shaft 1602to couple with the docking rod 1506 by sliding the docking rod 1506through the through holes of the coupling hoops 1612 along the axis. Insome embodiments, one or more of the coupling hoops 1612 are able to beonly partial hoops or C-shaped such that they do not form a full loop.In such embodiments, the hoops 1612 are able to still have greater thanfifty percent of the loop as a part of the C-shape in order to hold thedocking rod 1506 within the C-shape. Although as shown in FIGS. 16A-D,the shaft 1602 has two hoops 1612, more or less hoops 1612 are able tobe used.

The handle 1604 is able to comprise a docking channel 1614 configuredfor receiving a portion of the docking rod 1506. Specifically, thedocking channel 1614 is able to be aligned with the single axis of thehoops 1612 such that the handle 1604 is able to couple with the dockingrod 1506 at the same time as the shaft 1602 by sliding the docking rod1506 along the axis through the coupling loops 1612 and into the dockingchannel 1614. In some embodiments, the docking channel 1614 is sizedsuch that when the docking rod 1506 is fully slid into the channel 1614(and through the hoops 1612) the exit aperture 1610 is aligned with oneof the channels 120 of the bone fusion device 1504. Alternatively, thedocking channel 1614 is able to be sloped to become shallower toward theback end of the handle 1604 such that the docking rod 1506 is guidedaway from the delivery member 1502 as the docking rod 1506 extendsbeyond the back of the docking channel 1614.

FIG. 17 illustrates the docking rod 1506 according to some embodiments.As shown in FIG. 17, the docking rod 1506 is able to have a long tubularbody 1702 and a tapered tip 1704 at one or both ends of the body 1702.In particular, the tip 1704 is able to be sized and flexible such thatit is able to slid into and thereby detachably couple to the positioningaperture 134 of the bone fusion device 1504 (e.g. via a friction fit).In some embodiments, the body 1702 and/or tips 1704 of the docking rod1506 are able to be made of nitinol. Alternatively, the body 1702 and/ortips 1704 of the docking rod 1506 are able to be made of other materialsand/or a combination of other materials and nitinol. In someembodiments, the docking rod 1506 is able to be flexible.

FIGS. 18A-D illustrate an exploded perspective view, a side view, a sidecross-sectional view and a frontal view, respectively, of a short rigidplunger 1800 of the plungers 1508 according to some embodiments. Asshown in FIGS. 18A-D, the short rigid plunger 1800 comprises a handle1802, a screw 1804, a screw cap 1806 and a plunger head 1808. The handle1802 and plunger head 1808 are coupled to opposite ends of the screw1804 by screwing onto threading on either end of the screw 1804.Alternatively, other fastening methods are able to be used to couple thehandle 1802 and head 1808 to the screw 1804 and the threading on theends of the screw 1804 is able to be omitted. The head 1808 is able tohave a diameter or circumference that is equal to or slightly smallerthan the diameter and/or circumference of the inner surface of thefunnel 1606 of the delivery member 1502. As a result, the head 1808 isable to slide into the funnel 1606 (e.g. adjacent to or contacting theinner walls of the funnel) and thereby push material down through thefunnel into the shaft 1602 without the material escaping around the head1808 between the head 1808 and the side walls of the funnel 1606.Additionally, the tapering portion of the head 1808 that points awayfrom the screw 1804 is able to substantially match the contours of thebottom or funneling portion of the inner surface of the funnel 1606. Asa result, the head 1808 is able to extend to the bottom of the funnel1606 and push any remaining material out of the hole at the tip of thefunnel 1606.

The cap 1806 has a hollow tubular body having a threaded inner surfacethat surrounds an inner cavity 1810. At one end of the inner cavity 1810(facing the handle 1802), the cavity 1810 is bounded by a wall 1812having a central screw aperture 1814 with a threaded inner aperturesurface. At the other end of the cavity 1810 (facing the head 1808),there is no end wall and instead the cavity 1810 is exposed to theexterior of the body of the cap 1806. The size (e.g.

diameter, radius, circumference), shape and threading of the inneraperture surface of the screw aperture 1814 is configured such that thecap 1806 is able to thread onto (and thereby couple to) a middlethreaded portion of the screw 1804 in between the base of the handle1802 and the base of the head 1806 when they are coupled to the ends ofthe screw 1804. As a result, head 1808 (and/or the screw 1804 and handle1802) are able to move with respect to the cap 1806 by rotating the cap1806 and the screw 1804 with respect to each other such that thethreaded engagement between the two causes the cap 1806 to move up ordown the screw 1804 depending on the direction of rotation.

The size (e.g. diameter, radius, circumference), shape and threading ofthe inner cavity surface of the inner cavity 1810 is configured suchthat the cap 1806 is able to thread onto (and thereby couple to) thethreaded outer surface of the back end of the funnel 1606 of thedelivery member 1502. Thus, when the short rigid plunger 1800 is coupledto the funnel 1606 (via threading the cap 1806 onto the back end of thefunnel 1606), a user is able to closely control the plunging of the head1808 into the funnel 1606 by controlling the rotation of the screw 1804via the handle 1802 (which controls how much the screw 1804 pushes thehead 1808 into or out of the funnel 1606. In some embodiments, the shortrigid plunger 1800 is sized such that when the head 1808 is fullyextended away from the cap 1806 (e.g. the cap 1806 has reached the baseof the handle 1802 and/or the end of the central threading of the screw1804 near the handle 1802) while the cap 1806 is coupled to the funnel1606, the tapered end of the head 1808 abuts or contacts thebottom/funneling inner surface of the funnel 1606.

FIGS. 19A and 19B illustrate an exploded perspective view and a frontalview, respectively, of a long rigid plunger 1900 of the plungers 1508according to some embodiments. In particular, the long rigid plunger1900 is able to be substantially similar to the short rigid plunger 1800except for the differences described herein. As shown in FIGS. 19A-B,similar to the short rigid plunger 1800, the long rigid plunger 1900comprises a handle 1902, a screw 1904, a screw cap 1906 and a plungerhead 1908. Unlike the short rigid plunger 1800 however, both the head1908 and a portion of the screw 1904 coupled to the head 1908 are ableto have diameters or circumferences that are equal to or slightlysmaller than the diameter and/or circumference of the inner surface ofthe shaft 1602 of the delivery member 1502. As a result, the head 1908and the portion of the screw 1904 are able to slide into the shaft 1602(e.g. entering through the funnel 1606 and then sliding adjacent to orcontacting the inner walls of the shaft) and thereby push material downthrough the shaft 1602 to and out of the exit aperture 1610 without thematerial escaping around the head 1908 between the head 1908 and theside walls of the shaft 1602. Thus, after the material has been pushedfrom the funnel 1606 in to the shaft by the short plunger 1800, the longplunger 1900 is able to push the material out the exit aperture 1610into the bone fusion device 1504. Additionally, the tapering portion ofthe head 1908 that points away from the screw 1904 is able tosubstantially match the contours of the end portion of the inner surfaceof the shaft 1602/exit aperture 1610.

Like the short plunger 1800, when the long rigid plunger 1900 is coupledto the funnel 1606 (via threading the cap 1906 onto the back end of thefunnel 1606), a user is able to closely control the plunging of the head1908 into the funnel 1606 and through the shaft 1602 by controlling therotation of the screw 1904 via the handle 1902 (which controls how muchthe screw 1904 pushes the head 1908 into or out of the funnel 1606/shaft1602. In some embodiments, the long rigid plunger 1900 is sized suchthat when the head 1908 is fully extended away from the cap 1906 (e.g.the cap 1906 has reached the base of the handle 1902 and/or the end ofthe central threading of the screw 1904 near the handle 1902) while thecap 1806 is coupled to the funnel 1606, the tapered end of the head 1908abuts or contacts the end inner surface of the shaft 1602 at the exitaperture 1610.

FIGS. 20A-C illustrate an exploded perspective view, a side view and afrontal view, respectively, of a flexible plunger 2000 of the plungers1508 according to some embodiments. As shown in FIGS. 20A-C, theflexible plunger 2000 comprises a handle 2002, a coupling collar 2004, acrimp tube 2006 and one or more flexible rods 2008 a, 2008 b. The handle2002 is threadably coupled onto a first end of the coupling collar 2004and the crimp tube 2006 is threadably coupled into the second end of thecoupling collar 2004 with the flexible rods 2008 a, 2008 b fixedly heldwithin the channel through the crimp tube 2006. Alternatively, thehandle 2002 and/or the crimp tube 2006 are able to be coupled to thecoupling collar 2004 via different or additional fasteners as are knownin the art. Alternatively, two or all three of the crimp tube 2006, thecoupling collar 2004 and the handle 2002 are able to be formed as asingle integrated component.

The flexible rods 2008 and/or the crimp tube 2004 are able to havediameters or circumferences that are smaller than the diameter and/orcircumference of the inner surface of the shaft 1602 of the deliverymember 1502. As a result, flexible rods 2008 and/or the crimp tube 2006are able to slide into the shaft 1602 (e.g. entering through the funnel1606) and thereby break up blockages and push material down through theshaft 1602 to and out of the exit aperture 1610. In particular, theflexible plunger 2000 is able to be sized to have a length such thatwhen the flexible plunger 2000 is fully inserted into the deliverymember 1502 (e.g. further insertion is blocked by the handle 2002contacting the end of the funnel 1606 or the coupling collar 2004contacting the bottom inner surface of the funnel 1606), the tip of oneor more of the rods 2008 abuts or contacts the end inner surface of theshaft 1602 at the exit aperture 1610.

In some embodiments, the crimp tube 2006 comprises a single channel suchthat all of the flexible rods 2008 fit within the single channel.Alternatively, the crimp tube 2006 is able to comprise a plurality isisolated channels such that each rod 2008 is able to be fixedly held ina separate channel. As shown in FIGS. 20A-C, the rods 2008 are able tooffset within the crimp tube 2006 such that the tip of one of the rods2008 a extends further from the end of the crimp tube 2006 than the tipof the other of the rods 2008 b. Specifically, this aids the rods inclearing out material stuck within the shaft 1602. Alternatively, therods 2008 are able to be not offset within the crimp tube 2006, but havedifferent lengths such that their tips are still offset. Alternatively,the tips of the rods 2008 are able to be not offset either via the rods2008 themselves not being offset in the crimp tube 2006 (and the samelength) or being offset in the crimp tube 2006 but having lengths suchthat the tips are still aligned (i.e. the portion of the rods 2008extending out from the crimp tube 2006 is of an equal length).

Although as shown in FIGS. 20A-C, the plunger 2000 comprises twoflexible rods 2008, more or less flexible rods 2008 are able to be used.In some embodiments, some or all of the flexible rods 2008 are coupledtogether lengthwise along the entire portion that they are adjacent(e.g. lengthwise) such that the rods 2008 must flex together at thatportion. Alternatively, the rods 2008 are able to be formed as a singlemulti-rod. Alternatively, the rods 2008 are able to be uncoupled at someor all of the entire portion that the rods 2008 are adjacent. Forexample, the entirety of the portion of the rods 2008 that extend outfrom the crimp tube 2006 (e.g. the exposed portion) are able to bedisconnected such that they are able to flex separately. In someembodiments, the flexible rods 2008 are made of nitinol. Alternatively,the flexible rods 2008 are able to be made of other flexible materialsor combinations of other flexible materials and/or nitinol as are knownin the art.

A method of operation of the bone fusion system 1500 according to someembodiments will now be discussed in conjunction with the flow chartshown in FIG. 21. In some embodiments, the method described in FIG. 21is able to be combined with the method described in FIG. 14. The userslides the docking rod 1506 through the central hollow channel of theinsertion instrument 802 and couples the tip 1704 of the docking rod1506 into/with the positioning aperture 134 of the bone fusion device1504 at the step 2102. The user spreads the fingers 903 by rotating thecontrol sleeve 908 to the open or spread position thereby removing thefingers 903 from the gripping apertures 128 and out of the channels 122at the step 2104. The user then removes the insertion instrument 802from the patient leaving the docking rod 1506 coupled to the bone fusiondevice 1504 at the step 2106. The user couples the delivery member 1502onto the docking rod 1506 until the exit aperture 1610 is aligned withone or more of the channels 120 of the device 1504 at the step 2108. Insome embodiments, the coupling comprises sliding the docking rod 1506through one or more of the coupling hoops 1612 and/or into the dockingchannel 1614. In some embodiments, the coupling comprises abutting thecorner of an L-shape of the exit aperture 1610 with a side corner of thebone fusion device 1504 such that the L-shape is substantially alignedwith the two sides of the device 1504 that meet to create the sidecorner.

The user prepares and inserts desired material into the cavity of thefunnel 1606 of the delivery member 1502 at the step 2110. The user thenpushes the material through the funnel 1606 and the shaft 1602 out theexit aperture 1610 and into the bone fusion device 1504 using one ormore of the plungers 1508 at the step 2112. In some embodiments, whenthe use of the plungers 1508 comprises using the short rigid plunger1800, this use is able to comprise coupling the short rigid plunger 1800to the end of the funnel 1606 and turning the handle 1802 such that thehead 1808 pushes further into the funnel 1606 (e.g. until all of thematerial has been pushed into the shaft 1602 or the head 1808 contactsthe bottom of the funnel 1606). Alternatively, the coupling is able tobe omitted. In some embodiments, when the use of the plungers 1508comprises using the long rigid plunger 1900, this use is able tocomprise coupling the long rigid plunger 1900 to the end of the funnel1606 and turning the handle 1902 such that the head 1908 pushes furtherinto the shaft 1602 (e.g. until all of the material has been pushedthrough the shaft 1602 and/or out of the exit aperture 1610 or the head1908 contacts the bottom of the shaft 1602 defining the exit aperture1610). Alternatively, the coupling is able to be omitted. In someembodiments, when the use of the plungers 1508 comprises using theflexible plunger 2000, this use is able to comprise sliding the plunger2000 into and/or out of the shaft 1602 and/or the funnel 1606 in orderto break up any stuck or blocking portion of the material. In someembodiments, the delivery member 1502 is able to be rotated 180 degreesabout the docking rod 1502 such that the exit aperture 1610 aligns witha channel 120 on the opposite side of the device 1504 in order toprovide material through both the first channel 120 and the otherchannel 120.

Once a desired amount of the material has been delivered to the device1504, the user removes or decouples the delivery member 1502 and/ordocking rod 1506 from the bone fusion device 1504 at the step 2114. Insome embodiments, the user decouples the delivery member 1502 from thedocking rod 1506 before decoupling the docking rod 1506 from the device1504. Alternatively, the user decouples the docking rod 1506 from thedevice 1504 while the delivery member 1502 is still coupled to thedocking rod 1506. In some embodiments, decoupling the delivery member1502 from the docking rod 1506 comprises sliding the delivery member1502 off the docking rod 1506 until the docking rod 1506 slides out ofthe docking channel 1614 and/or out of the coupling hoops 1612. As aresult, the method provides the advantage of enabling desired material(e.g. bone graft material) to easily be delivered to the bone fusiondevice 1504 after it is already positioned within a patient and/or withthe plates 130 already expanded to the desired height (which increasedthe empty volume within the body of the device 1504. In someembodiments, one or more of the steps of the methods 1300 and/or 2100are able to be omitted. For example, if the measuring tool 1100 and/orthe engaging tool 1200 are not desired the steps involving one or bothof the tools are able to be omitted or performed without that aspect. Asanother example, if bone graft material is not necessary, the stepsinvolving the packing of the bone graft material using the deliveryapparatus 1502 is able to be omitted.

Removal/Repositioning Tools

FIG. 22 illustrates a redocking tool 2200 according to some embodiments.As shown in FIG. 22, the redocking tool 2200 comprises base 2202 coupledto an elongated arm or rod 2204 having a redocking tip 2206. Theelongated arm 2204 is able to be tubular and/or sized to slide androtate within the central hollow channel of the insertion instrument 802along the axis 900. The tip 2206 is able to be configured (e.g.contoured) to operably fit within or otherwise interface with thepositioning aperture 134 of the device 804 such that when positionedwithin the aperture 134, rotation of the tip 2206 causes the positioningcomponent 108 to correspondingly rotate. For example, the tip 2206 isable to have a hexagonal shape, a star-shape, a flat-head shape, aPhilips head shape or other types of bit shapes as are known in the art.Alternatively, the tip 2206 is able to be shaped and/or couple to thepositioning aperture 134 in the same manner as the tapered tip 1704 ofthe docking rod 1506. The length of the longest dimension of theredocking tool 2200 is able to be greater than the length of the longestdimension of the insertion instrument 802 such that when inserted intothe central hollow channel the tool 2200 protrudes from one or both endsof the instrument 802. As a result, should an implanted device ever needto be removed or otherwise adjusted, the tip 2206 of the redocking tool2200 is able to be coupled to the positioning aperture 134 of the device804 and then the insertion instrument 802 slid down on the redockingtool 2200 thereby guiding the insertion instrument 802 to align with thedevice 804 in order to re-couple to the device 804 (as described above).In some embodiments, the redocking tool 2200 is slid into the insertioninstrument 802 before the tip 2206 is coupled to the positioningaperture 134. Alternatively, the insertion instrument 802 is able toslid onto the redocking tool 2200 after the tip 2206 is coupled to thepositioning aperture 134.

FIG. 23 illustrates a method of redocking with a bone fusion deviceaccording to some embodiments. As shown in FIG. 23, a user couples theredocking tool 2200 to the bone fusion device 804 by sliding the tip2206 into the positioning aperture 134 of the device 804 at the step2302. The user slides the insertion instrument 802 onto the redockingtool 2200 through the central hollow channel at the step 2304.Alternatively, the insertion instrument 802 is able to be slid onto theredocking tool 2200 before the redocking tool 2200 is coupled to thedevice 804. The user slides the insertion instrument 802 to the end ofthe redocking tool 2200 where the redocking tool 2200 meets the device804 such that the fingers of the insertion instrument 802 are alignedwith the channels 120 of the device 804 at the step 2306. The user thendetachably couples the insertion instrument 802 to the device 804 at thestep 2308. In some embodiments, the coupling of step 2208 is able to besubstantially similar to steps 1406-1410 described above with referenceto FIG. 14. The user removes or repositions the device 804 with theinsertion instrument 802 at the step 2310. In some embodiments, theremoval/repositioning comprises retracting the tabs/plates 130 using theengaging tool 1200 as described above. In such embodiments, theredocking tool 2200 is able to be removed from the central hollowchannel to make room for the engaging tool 1200. Alternatively, theredocking tool 2200 is able to be rotated while coupled with thepositioning aperture 134 in order to retract the tabs/plates 130. As aresult, the method provides the advantage of enabling a device 804 to beremoved or repositioned by safely guiding the insertion instrument 802such that it is able to re-couple with the device 804.

FIGS. 24A and 24B illustrate a rescue hook 2400 according to someembodiments. As shown in FIG. 24A, the rescue hook 2400 comprises a base2402 having a hook orientation indicator 2403 and coupled to anelongated arm or rod 2404 having a rescue hook 2406. The indicator 2403is able to have an orientation that matches the rescue hook 2406 suchthat viewing the indicator 2403 is able to indicate the orientation ofthe rescue hook 2406. The elongated arm 2404 is able to be tubular. Asshown in FIG. 24B, the hook 2406 is able to be sized such that thehooking portion is able to fit within one or more of the channels 120 ofthe device 804. In particular, the well created by the hook 2406 is ableto be sized and/or contoured such that it is able to wrap around a sidewall of the device 802 while being inserted into one of the channels 120of the device 802 (thereby “hooking” the device 802). Alternatively, thehook 2406 is able to be inserted into any apertures on any sides of thedevice 802. As shown in FIG. 24, the well of the hook 2406 is rounded.Alternatively, the well of the hook 2406 is able to be squared (e.g.having two 90 degree turns) or otherwise be non-curved (e.g. coming toone or more concave points/edges) in order to form the U or hook shape.In some embodiments, the indicator 2403 is positioned on both sides ofthe base 2402. Alternatively, the indicator 2403 is able to bepositioned on a single side of the base 2402. In some embodiments, twoor more rescue hooks 2400 are able to be used simultaneously orconcurrently to retrieve a device 802. For example, two hooks 2406 areable to be inserted into channels 120 on opposite sides of the device802 at the same time to provide more stability in retrieving the device802 with the rescue hooks 2400.

FIG. 25 illustrates a method of using a rescue hook 2400 according tosome embodiments. As shown in FIG. 25, a user positions the hook 2406 ofthe rescue hook 2400 proximate the bone fusion device 804 at the step2502. The user rotates the rescue hook 2400 such that the hook tip 2406extends toward a channel 120 of the device 804 at the step 2504. In someembodiments, the user determines the orientation of the hook tip 2406based on the indicator 2403 (e.g. the orientation of a hook marking ofthe indicator). The user detachably couples the rescue hook 2400 to thedevice 804 at the step 2506. In some embodiments, the coupling comprisesinserting the rescue hook 2406 into the channel 120 of the bone fusiondevice 804. In some embodiments, the insertion comprises moving the hook2400 such that a portion of the side wall of the device 804 defining thechannel 120 slides into the well of the hook tip 2406. The user removesor repositions the device 804 by manipulating the rescue hook 2400 whilethe rescue hook 2400 is coupled to the device 804 at the step 2508. Insome embodiments, step 2506 is able to be repeated with one or moreadditional hooks 2400 such that step 2508 is able to include themanipulating of each of the rescue hooks 2400 coupled to the device 804in step 2506. Thus, the rescue hook 2400 provides the advantage ofenabling a bone fusion device 804 to be removed or repositioned ifnecessary even if the device 804 cannot be re-docked with due to itsposition within the patient.

Additionally, it should be noted that although described separately fromthe insertion and measurement system and the material delivery system,the redocking tool 2200 and/or rescue hook 2400 are able to be a part ofone or both of the systems. Similarly, although described separatelyfrom the insertion and measurement method and the material deliverymethod, the redocking tool method and/or rescue hook method are able tobe combined with one or both of the methods.

Thus, the bone fusion device, apparatus and method described herein hasnumerous advantages. Specifically, the system and method provide theadvantage of enabling the bone fusion device to be safely positioned andexpanded using the insertion instrument. Further, they provide theadvantage of enabling the precise measurement of the expansion level ofthe tabs of the bone fusion device using the measurement system.Moreover, they provide the advantage of enabling desired material to besafely delivered to the bone fusion device while positioned within apatent using the bone graft delivery apparatus and docking rod and inthe desired quantity. They provide the advantage of enabling redockingwith the device after in position using the redocking rod and/orrecovering or moving a bone fusion device that cannot be accessed by theredocking rod using the rescue hook rod. Additionally, the fingers andfingertips coupled to the channels having gripping apertures ensure thenon-slippage of the driving mechanism during the operation of the bonefusion apparatus. Also, as mentioned above, the method of use requiresonly a small incision and minimally invasive surgical procedureadvantageously promoting health and rapid recovery by the patient.Indeed, bone growth occurs around the bone fusion device andparticularly at the locations of the extended tabs, such that the bonefusion device is further secured by the bone growth, which furtherpromotes a superior, robust bone fusion result. Additionally, theinsertion instrument has a hollow central channel that enables the drivemechanism and/or a docking rod to be selectively removed or insertedinto the positioning aperture as desired. Similarly, the hollow centralchannel of the delivery apparatus enables multiple different types ofplungers to be used in concert to precisely deliver material to and/orwithin the bone fusion device.

The present invention has been described in terms of specificembodiments incorporating details to facilitate the understanding ofprinciples of construction and operation of the invention. Suchreference herein to specific embodiments and details thereof is notintended to limit the scope of the claims appended hereto. It will beapparent to those skilled in the art that modification may be made inthe embodiments chosen for illustration without departing from thespirit and scope of the invention. For example, although the systems aredescribed above separately, one or more components of two or more of thesystems are able to be combined into a single system. Further, it shouldbe noted that although the above bone fusion devices are described inreference to a pair of extending blocks, a pair of screws, and whereineach tab is shaped such that the ends are larger than the middle, andthe size of the tab gradually increases while going from the middle tothe ends, the use of a single extending block in the above embodimentsis contemplated. Specifically, if using a single extending block, theabove embodiments would operate the same except the positioning meanswould comprise a single screw that when engaged would cause the singleextending block to move from one end of the screw to the other endthereby exerting a force against the tabs such that they move into theextended position. In such embodiments, each tab is shaped such that oneend is larger than the opposite end, and the size of the tab graduallyincreases going from the smaller end to the larger end.

1. A bone fusion surgical system for manipulating a bone fusion devicein a desired location, the system comprising: a bone fusion devicehaving a body with one or more device channels, a positioning elementhaving a positioning aperture and one or more extendable tabs, whereinmanipulation of the positioning element enables the tabs to be extendedaway from the body; and a rescue hook rod having an elongated arm with abase handle at a first end and a hook at a second end opposite the firstend, wherein a surface of the base handle includes a first visualindicator that indicates an orientation of the hook with respect to thebase handle.
 2. The system of claim 1, wherein at least one of thedevice channels has a channel height and is positioned along a side ofthe bone fusion device such that a perimeter of the one of the devicechannels is defined by a side wall of the body, wherein the side wallhas a side wall width.
 3. The system of claim 2, wherein the hook formsa U-shape and the width of the U-shape is slightly greater than the sidewall width such that the side wall is able to slide into the hook withinthe U-shape.
 4. The system of claim 3, wherein the U-shape formed by thehook parallel to a plane, and perpendicular to the plane, the hook has ahook width that is less than the channel height such that the hook isable to slide into the channel.
 5. The system of claim 4, wherein thefirst visual indicator is positioned on a first side of the base handleand a second visual indicator is positioned on a second side of the basehandle, wherein the second visual indicator indicates the orientation ofthe hook with respect to the base handle.
 6. The system of claim 5,further comprising an insertion instrument having a coupling mechanismhaving a control rod and a plurality of fingers configured to movebetween a closed position wherein the fingers are close together to aspread position wherein the fingers are farther apart based onmanipulation of the control rod.
 7. The system of claim 6, wherein thecontrol rod has a hollow axial cavity that extends from a bottom of theplurality of fingers to an opposite end of the instrument.
 8. The systemof claim 7, further comprising a measuring tool comprising: a housingincluding a gear chamber and a screw chamber; a screw that extendsthrough the screw chamber and is rotatably coupled within the housingsuch that the screw is able to rotate about a screw axis within thescrew chamber; an indicator ring threaded onto the screw within thescrew chamber such that rotation of the screw causes the ring to move upor down the screw a distance along the screw axis; a screw gearpositioned within the gear chamber and coupled to a first screw end endof the screw and centered around the screw axis such that rotation ofthe screw gear causes rotation of the screw; and an offset gearpositioned within the gear chamber offset from the screw axis andoperably coupled with the screw gear such that rotation of the gearwheel causes the screw gear to correspondingly rotate, wherein a numberof rotations of the screw gear in a direction is proportional to thedistance moved by the ring caused by the rotation of the screw gear. 9.The system of claim 8, further comprising an engaging tool comprising: aengaging handle having a bottom; an elongated member having a tip endincluding a contoured tip and a coupling end opposite the tip end andcoupled to the bottom of the engaging handle; and an interface gearhaving a set of teeth and coupled to the bottom of the engaging handlesuch that the set of teeth are centered around the elongated member. 10.The system of claim 9, further comprising a delivery apparatus includinga docking rod and a delivery member having an elongated hollow shaftthat leads to an exit aperture, wherein a tip of the docking roddetachably couples to the bone fusion device within the positioningaperture and the delivery member detachably couples with the docking rodsuch that the exit aperture aligns with the one of the device channelswhen the docking rod is coupled to the bone fusion device.
 11. Thesystem of claim 8, wherein the delivery apparatus includes a rigidplunger comprising: a rigid plunger handle; a plunger head; a plungerrod having a first rod end coupled to the rigid plunger handle and asecond rod end coupled to the plunger head, wherein the plunger rod hasa threaded portion between the rigid plunger handle and the plungerhead; and a plunger hollow tubular cap having an opening at a first capend, a wall including a screw aperture at a second cap end and athreaded inner tubular wall between the first cap end and the second capend, wherein an inner surface of the screw aperture is threaded and theplunger hollow tubular cap is threaded onto threaded portion of theplunger rod in between the rigid plunger handle and the plunger head.12. The system of claim 9, wherein the delivery apparatus includes aflexible plunger comprising: a gripping handle; a first flexible rod; asecond flexible rod; and a sleeve coupled with the gripping handle,wherein the sleeve holds the first flexible rod adjacent to the secondflexible rod in an area such that the first and second flexible rods areheld next to each other within the area, but able to flex away from eachother outside of the area.
 13. The system of claim 1, further comprisingan additional rescue hook rod that matches the rescue hook rod. 14-22.(canceled)
 23. A method of operation of a bone fusion system, the methodcomprising: providing a bone fusion device in a desired location, thebone fusion device having a body with one or more device channels, apositioning element having a positioning aperture and one or moreextendable tabs, wherein manipulation of the positioning element enablesthe tabs to be extended away from the body; providing a rescue hook rodhaving an elongated arm with a base handle at a first end and a hook ata second end opposite the first end, wherein a surface of the basehandle includes a first visual indicator that indicates an orientationof the hook with respect to the base handle; coupling the rescue hookrod with the bone fusion device by inserting the hook into one of thedevice channels; and repositioning the bone fusion device bymanipulating the rescue hook rod.
 24. The method of claim 23, wherein atleast one of the device channels has a channel height and is positionedalong a side of the bone fusion device such that a perimeter of the oneof the device channels is defined by a side wall of the body, whereinthe side wall has a side wall width.
 25. The method of claim 24, whereinthe hook forms a U-shape and the width of the U-shape is slightlygreater than the side wall width such that the side wall is able toslide into the hook within the U-shape.
 26. The method of claim 25,wherein the U-shape formed by the hook parallel to a plane, andperpendicular to the plane, the hook has a hook width that is less thanthe channel height such that the hook is able to slide into the channel.27. The method of claim 26, wherein the first visual indicator ispositioned on a first side of the base handle and a second visualindicator is positioned on a second side of the base handle, wherein thesecond visual indicator indicates the orientation of the hook withrespect to the base handle.
 28. The method of claim 27, furthercomprising providing an insertion instrument having a coupling mechanismhaving a control rod and a plurality of fingers configured to movebetween a closed position wherein the fingers are close together to aspread position wherein the fingers are farther apart based onmanipulation of the control rod.
 29. The method of claim 28, whereinproviding the bone fusion device in the desired location comprises:spreading the plurality of fingers with the control rod; sliding thefingers into one or more of the channels of the bone fusion device;contracting the fingers with the control rod such that the fingers moveinto the one or more of the channels and the insertion instrument isdetachably coupled with the bone fusion device; and positioning the bonefusion device into the desired position by manipulating the insertioninstrument.
 30. The method of claim 23, further comprising providing anadditional rescue hook rod that matches the rescue hook rod; couplingthe additional rescue hook rod with the bone fusion device by insertingan additional hook of the additional rescue hook rod into a differentone of the device channels, wherein repositioning the bone fusion deviceincludes manipulating both the rescue hook rod and the additional rescuehook rod. 31-35. (canceled)